Healthcare News

  • Wednesday, February 20, 2019
    • Bausch Health Companies (NYSE:BHC): Q4 Non-GAAP net income of $368M
    • GAAP net loss of $344M
    • Revenue of $2.12B (-1.9% Y/Y) beats by $40M.
    • Shares +1.23% PM.
    • Press Release
    • The FDA grants Priority Review for Merck's (NYSE:MRK) supplemental marketing application seeking approval to use Keytruda (pembrolizumab) to treat patients with advanced small cell lung cancer (SCLC) who have progressed after two or more prior lines of therapy. The agency's action date is June 17.
    • CVS Health (NYSE:CVS): Q4 Non-GAAP EPS of $2.14 beats by $0.05; GAAP EPS of -$0.37 misses by $2.13.
    • Revenue of $54.42B (+12.5% Y/Y) misses by $190M.
    • Shares -3.16% PM.
    • Press Release
    • Fresenius SE & Co. KGaA (OTCQX:FSNUF): Q4 Non-GAAP EPS of €0.91; GAAP EPS of €0.93.
    • Revenue of €8.84B (+1.6% Y/Y)
    • Press Release
    • Fresenius Medical Care (NYSE:FMS): Q4 Non-GAAP EPS of €1.15; GAAP EPS of €1.38.
    • Revenue of €4.3B (-2.9% Y/Y)
    • Shares +3.91% PM.
    • Press Release
  • Tuesday, February 19, 2019
    • Cellular Biomedicine (NASDAQ:CBMG): FY GAAP EPS of -$2.20 misses by $0.60.
    • Revenue of $0.22M (-35.3% Y/Y) misses by $0.08M.
    • Press Release
    • Teva Pharmaceutical Industries (NYSE:TEVA) has settled with the Federal Trade Commission to resolve all outstanding litigation.
    • That includes the FTC dropping claims against Teva and affiliates across three outstanding cases, as well as modifications to some terms from a 2015 consent decree.
    • Those three cases are FTC v. AbbVie (NYSE:ABBV); FTC v. Actavis; and FTC v. Allergan (NYSE:AGN). The consent decree was originally entered in FTC v. Cephalon.
    • Teva won't pay any additional money to the FTC as part of the settlement.
    • A settlement with the FTC calls for Fresenius Medical Care (NYSE:FMS) and NxStage Medical (NASDAQ:NXTM) to divest rights and assets tied to NxStage's bloodline tubing set business in order to consummate their acquisition deal.
    • The companies will divest the business to B. Braun Medical to resolve charges that the $2B deal would be anticompetitive.
    • The sets are single-use plastic tube sets used during hemodialysis treatments.
    • Fresenius and NxStage are two of only three significant suppliers of such sets, together controlling about 82% of the market for bloodlines.
    • After hours: FMS +1%.
    • Vical (NASDAQ:VICL): Q4 GAAP EPS of -$0.17.
    • Cash and investments of $50.5M
    • Press Release
    • Genomic Health (NASDAQ:GHDX) is scheduled to announce Q4 earnings results on Wednesday, February 20th, after market close.
    • Community Health Systems (NYSE:CYH) is scheduled to announce Q4 earnings results on Wednesday, February 20th, after market close.
    • NuVasive (NASDAQ:NUVA) is scheduled to announce Q4 earnings results on Wednesday, February 20th, after market close.
    • Agilent (NYSE:A) is scheduled to announce Q1 earnings results on Wednesday, February 20th, after market close.
    • CVS Health (NYSE:CVS) is scheduled to announce Q4 earnings results on Wednesday, February 20th, before market open.
    • Bausch Health Companies (NYSE:BHC) is scheduled to announce Q4 earnings results on Wednesday, February 20th, before market open.
    • Novartis (NYSE:NVS) unit Sandoz commences the U.S. commercial launch of its generic version of Indivior's (OTCPK:INVVY) opioid dependence med Suboxone (buprenorphine and naloxone) in all four dosage strengths.
    • Sienna Biopharmaceuticals (NASDAQ:SNNA) slumps 15% after hours in response to its planned stock offering. Price, volume and terms have yet to be announced.
    • Tivity Health (NASDAQ:TVTY) Q4 results ($M): Revenues: 153.0 (+9.8%).
    • Net income: 28.5 (+235.3%); non-GAAP net income: 30.9 (+75.6%); EPS: 0.70 (+233.3%); non-GAAP EPS: 0.73 (+78.0%); non-GAAP EBITDA: 37.0 (+24.2%).
    • Cash flow ops (full year): 108.7 (+3.2%).
    • 2019 guidance: Revenues: $1,146M - 1,177M; non-GAAP EBITDA: $240M - 258M (includes Nutrisystem).
    • Shares are down 8% after hours.
    • Previously: Tivity Health beats by $0.15, misses on revenue (Feb. 19)
    • Lantheus Holdings (NASDAQ:LNTH) Q4 results highlights:
    • Revenues up 6.3% to $86.3M, earnings down 86.3% to $13.3M due to a $85.9M tax benefit the year before. EPS down 86.2% to $0.34.
    • Non-GAAP net income was up 130.6% to $11.3M. Non-GAAP EPS was up 141.7% to $0.29.
    • Q1 guidance: Revenue: $85.0M - 87.5M; non-GAAP EPS: $0.23 - 0.25.
    • 2019 guidance: Revenue: $358M - 363M; non-GAAP EPS: $1.14 - 1.17.
    • Shares are up 9% after hours.
    • Previously: Lantheus beats by $0.15, beats on revenue (Feb. 19)
    • Amedisys (NASDAQ:AMED) has agreed to acquire RoseRock Healthcare, a Tulsa, OK-based hospice care provider, for an undisclosed sum. The transaction should close on April 1.
    • RoseRock currently serves ~200 patients.
    • Shares are down a fraction after hours.
    • Edwards Lifesciences (NYSE:EW) PASCAL transcatheter valve repair system is now CE Mark certified for the treatment of mitral regurgitation.
    • Shares are up a fraction after hours.
    • A Phase 3 clinical trial, KEYNOTE-240, evaluating Merck's (NYSE:MRK) Keytruda (pembrolizumab) plus best supportive care in previously treated patients with advanced hepatocellular carcinoma (HCC) failed to meet the co-primary endpoints of overall survival (OS) and progression-free survival (PFS).
    • The key secondary endpoint of objective response rate (ORR) was not formally tested since the OS and PFS endpoints were not met.
    • The FDA granted accelerated approval for Keytruda in HCC patients previously treated with Bayer's Nexavar (sorafenib) in November 2018 based on Phase 2 data.
    • The results have been shared with the FDA and will be submitted for presentation at a future medical conference.
    • Shares are down 1% after hours.
    • Invitae (NYSE:NVTA): Q4 GAAP EPS of -$0.40 beats by $0.03.
    • Revenue of $45.36M (+78.6% Y/Y) beats by $4.34M.
    • Shares +1.76%.
    • Press Release
    • Herbalife Nutrition (NYSE:HLF) Q4 results ($M): Sales: 1,186.6 (+8.5%).
    • Net income: 48.9 (+177.1%); non-GAAP net income: 89.6 (-9.1%); EPS: 0.34 (+179.1%); non-GAAP EPS: 0.63 (-3.1%).
    • Cash flow ops (full year): 648.4 (+9.7%).
    • Volume points (M): Asia Pacific: 355.5 (+29.8%); North America: 280.5 (+11.8%); EMEA: 302.6 (+11.3%); Mexico: 228.6 (+10.1%); China: 155.2 (+3.7%); South & Central America: 138.6 (-9.4%); Global: 1,461 (+11.8%).
    • Q1 guidance: Volume point growth: 4.0 - 8.0%; sales growth: 0.5 - 4.5%; EPS: $0.51 - 0.61; non-GAAP EPS: $0.60 - 0.70.
    • 2019 guidance: Volume point growth: 4.0 - 8.0%; sales growth: 4.0 - 8.0%; EPS: $2.34 - 2.74; non-GAAP EPS: $2.70 - 3.10.
    • Previously: Herbalife beats by $0.02, revenue in-line (Feb. 19)
    • Tivity Health (NASDAQ:TVTY): Q4 Non-GAAP EPS of $0.73 beats by $0.15; GAAP EPS of $0.67 beats by $0.09.
    • Revenue of $153.04M (+9.8% Y/Y) misses by $0.98M.
    • Shares -2.64%.
    • Press Release
    • Herbalife (NYSE:HLF): Q4 Non-GAAP EPS of $0.63 beats by $0.02; GAAP EPS of $0.34.
    • Revenue of $1.19B (+9.2% Y/Y) in-line.
    • Shares -1.8%.
    • Press Release
    • LeMaitre Vascular (NASDAQ:LMAT): Q4 GAAP EPS of $0.30 beats by $0.10.
    • Revenue of $28.39M (+8.6% Y/Y) beats by $2.41M.
    • Shares +4.38%.
    • Press Release
    • Ultragenyx (NASDAQ:RARE) Q4 results ($M): Revenues: 16.3 (+579.2%); Crysvita-related revenue: 11.6.
    • Net loss: (87.8) (-7.5%); loss/share: (1.73) (+8.5%).
    • U.S. marketing application for UX007 in long-chain fatty acid oxidation disorders on track for mid-year.
    • Analyst day scheduled for Wednesday, April 17.
    • Previously: Ultragenyx Pharmaceutical beats by $0.05, beats on revenue (Feb. 19)
    • Lantheus (NASDAQ:LNTH): Q4 Non-GAAP EPS of $0.29 beats by $0.15; GAAP EPS of $0.34.
    • Revenue of $86.27M (+6.2% Y/Y) beats by $2.47M.
    • Press Release
    • Ultragenyx Pharmaceutical (NASDAQ:RARE): Q4 GAAP EPS of -$1.73 beats by $0.05.
    • Revenue of $16.26M (+574.7% Y/Y) beats by $2.66M.
    • Press Release
    • Accelerate Diagnostics (NASDAQ:AXDX): Q4 GAAP EPS of -$0.41 in-line.
    • Revenue of $1.8M (-14.3% Y/Y) misses by $0.06M.
    • Press Release
    • Intercept Pharmaceuticals (ICPT +6.5%) is up on almost a 12x surge in volume, although shares have retraced 11% from the intraday high of $131.87, following its announcement of positive results from a Phase 3 clinical trial evaluating top drug OCALIVA (obeticholic acid) in NASH patients with liver fibrosis.
    • Investors seem to have lost a bit of their initial enthusiasm since only one of the two co-primary endpoints was met. In addition, the side effect of dose-related pruritis (itchy skin), the most common adverse event, appears concerning. It was noted in 28% of patients receiving the 10 mg dose and 51% of those receiving the 25 mg dose, both above placebo's 19%. Severe pruritis occurred in 5% of patients in the 25 mg cohort compared to less than 1% for the 10 mg group and control. There was a 9% discontinuation rate in the 25 mg group due to severe itchy skin (less than 1% in the other two groups).
    • Another potential safety issue is OCA's effect on the liver and bile ducts. 3% of the patients in the 25 mg cohort experienced gallstones or cholecystitis (gallbladder inflammation) compared to 1% in the 10 mg cohort and less than 1% for placebo.
    • In a statement, Allergan (AGN -0.3%) says splitting the Chairman and CEO roles currently held by Brent Saunders, a change advocated by institutional shareholder Appaloosa LP, would be "highly disruptive" to the company and "diminish Mr. Saunders' ability to execute Allergan's strategy" to create a world-class business.
    • Throwing Appaloosa a bone, the company "supports" splitting the roles with the next leadership change.
    • Eli Lilly (LLY +0.3%) has filed a prospectus for an unspecified mixed shelf offering.
    • The USPTO's Patent Trial and Appeal Board has agreed to review two patents (Nos. 9,340,614 and 9,226,951) covering Teva Pharmaceutical Industries' (TEVA -0.3%) migraine med AJOVY (fremenezumab).
    • Competitor Eli Lilly (LLY -0.1%) filed the challenge after Teva claimed that its migraine med IMGALITY (galcanezumab-gnlm) infringed on Teva patents.
    • The U.S. Supreme Court has rejected the state of Maryland's appeal of an appeals court ruling that struck down its anti-price gouging law citing the illegality of state-level regulation of interstate commerce.
    • A trade group representing generic drugmakers filed the legal challenge to the law.
    • Maryland's law, enacted in 2017 after high-profile price hikes by certain pharma firms, including Turing Pharmaceuticals with Daraprim, prohibited "unconscionable" price increases for essential off-patent medicines or generics sold there.
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    • The FDA approves Novo Nordisk's (NVO +0.3%) long-acting factor VIII replacement therapy ESPEROCT (turoctocog alfa pegol) for adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding.
    • The company says it will not be able to launch the product in the U.S. before 2020 due to third-party intellectual property agreements.
    • Hemophilia A-related tickers: CBIO, OTCQX:RHHBY, BMRN, OTCPK:BAYRY, QURE, SGMO, ONCE, TAK, ALNY, SNY
    • The European Commission approves Pfizer's (PFE +0.9%) ZIRABEV, a biosimilar to Roche's (OTCQX:RHHBY +0.9%) Avastin (bevacizumab).
    • The FDA grants 501(k) clearance for Intuitive Surgical's (ISRG -0.7%) Ion endoluminal system used to obtain biopsy tissue in the peripheral lung. The device uses an articulating robotic catheter to reach lung nodules in the airway.
    • Nano cap Adial Pharmaceuticals (ADIL -12.6%) is down on below-average volume on the heels of its prospectus for the public sale of 2,380,952 common shares (from ~1.9M), each with an accompanying warrant to purchase 3/4 of a share of common at 125% of the offering price.
    • Recro Pharma (REPH -0.2%) has filed a prospectus for a $100M mixed shelf offering.
    • Thinly traded Axonics Modulation Technologies (AXNX +9.2%) is up on modestly higher volume following its announcement of positive results from a pivotal study, ARTISAN-SNM, evaluating its implantable Axonics r-SNM neuromodulator for the treatment of urinary urgency incontinence.
    • At month 6, 90% (n=116/129) of implant recipients responded [defined as at least a 50% reduction from baseline in urgency incontinence episodes (UIEs)], including 80% with at least a 75% reduction in UIEs and 34% with a total elimination of UIEs (completely dry).
    • The company plans to submit the data to the FDA this week, adding that the additional results should not impact the standard 180-day review period for its recently filed (December 3, 2018) U.S. marketing application.
    • Gainers: Bioblast Pharma (NASDAQ:ORPN) +63%. Riot Blockchain (NASDAQ:RIOT) +36%. CHF Solutions (NASDAQ:CHFS) +18%. Conformis (NASDAQ:CFMS) +15%. MediciNova (NASDAQ:MNOV) +15%.
    • Losers: Pernix Therapeutics (NYSEMKT:PTX) -64%. Motif Bio (NASDAQ:MTFB) -19%. Adial Pharmaceuticals (NASDAQ:ADIL) -14%. Translate Bio (NASDAQ:TBIO) -12%. Melinta Therapeutics (NASDAQ:MLNT) -10%.
    • Nano cap Pernix Therapeutics (PTX -64.9%) slumps on a 6x surge in volume following is filing for Chapter 11 bankruptcy protection.
    • Concurrently, it has entered into an agreement with certain funds managed by Highbridge Capital Management, LLC to sell virtually all of its assets for $75.6M in cash and credit bid consideration. The deal is a "stalking horse bid" which sets the low end of the bidding range for other suitors, eliminating "low ball" offers. The company's current value is ~$6M.
    • Thinly traded nano cap CHF Solutions (CHFS +20%) is up on more than double normal volume, albeit on turnover of only 53K shares, in reaction to its agreement with Brazil's Bragenix LTDA for the in-country distribution of its Aquadex FlexFlow system. Financial terms are not disclosed.
    • Thinly traded nano cap Bioblast Pharma (ORPN +64%) is up a healthy 31x surge in volume on the heels of the sale of its Trehalose program to Seelos Therapeutics (SEEL -3.3%) for up to $20.5M.
    • Under the terms of the deal, ORPN will receive $3.5M, $1.5M upfront and $2.0M in a year, up to $17.0M in milestones plus royalties on net sales.
    • ORPN expects to finalize its merger with Enlivex Therapeutics Ltd. this quarter. It says current shareholders will have the opportunity to benefit from the success of Trehalose at Seelos via Contingent Value Rights (CVRs).
    • Trehalose, a protein stabilizing sugar molecule, is being developed to treat oculopharyngeal muscular dystrophy.
    • NanoViricides (NYSEMKT:NNVC): Q2 GAAP EPS of -$0.03 in-line.
    • Cash and cash equivalents of $3.9M
    • Press Release
    • Updated data from a Phase 1 clinical trial, CARPALL, evaluating Autolus Therapeutics' (AUTL -1.4%) CD19 CAR T candidate AUTO1 in heavily pretreated pediatric patients with acute lymphoblastic leukemia (ALL) showed a positive effect with a favorable safety profile. The results were presented at the European Hematology CAR T Cell Meeting in Paris.
    • 14 of 17 enrolled patients received a single infusion of AUTO1. 71% (n=10/14) had relapsed after allogeneic stem cell transplantation.
    • 86% (n=12/14) achieved molecular complete response (no evidence of cancer via CT or PET imaging). Five relapsed with CD19-negative cancer. At month 6, the rates of event-free survival (EFS) and overall survival (OS) were 67% and 84%, respectively. At month 12, EFS and OS rates were 46% and 63%, respectively.
    • 93% (n=13/14) experienced mild or moderate cytokine release syndrome (CRS). There were no cases of severe CRS and no patients required Roche's Actemra (tocilizumab) or steroids.
    • The company says AUTO1 has a better safety profile than other CAR T therapies with comparable efficacy.
    • CARPALL's estimated primary completion date is October 2020. It final completion date is December 2030.
    • Updated data from a Phase 1 clinical trial evaluating Calithera Biosciences' (CALA +4.1%) glutaminase inhibitor telaglenastat, combined with Exelixis' (EXEL -2.8%) Cabometyx (cabozantinib), in previously treated patients with advanced renal cell carcinoma (RCC) showed a positive effect. The results were presented at the ASCO GU Cancers Symposium in San Francisco.
    • The disease control rate (responders + stable cancer) was 100% (n=12/12), including five partial responders.
    • The results are not as dramatic as Merck's Keytruda + Pfizer's Inlyta which showed a 59% response rate, including almost a 6% complete response rate, albeit in first-line RCC.
    • The FDA accepts for review Assertio Therapeutic's (NASDAQ:ASRT) marketing application seeking approval for its injectable formulation of long-acting cosyntropin (synthetic adrenocorticotropic hormone, or ACTH) as a diagnostic drug in screening for adrenocortical insufficiency.
    • The application was filed under the 505(b)(2) pathway which allows the inclusion of data generated by others.
    • The agency's action date is October 19.
    • Thinly traded micro cap Intec Pharma (NASDAQ:NTEC) is up 1% premarket on light volume in response to positive preliminary results from a pharmacokinetic (PK) study comparing its Accordion Pill Carbidopa/Levodopa (AP-CD/LD) 50/500mg dosed three times daily to 1.5 tablets of CD/LD immediate release (Merck's Sinemet) 25/100 dosed five times per day in Parkinson's disease (PD) patients.
    • The study met the primary objective of demonstrating significantly less variability in the levodopa fluctuation index in patients receiving the Accordion Pill versus Sinemet (p<0.005).
    • Complete results will be submitted for presentation at a future medical conference and for publication.
    • The company says the Accordion Pill technology allows for the slow release of a drug in the stomach over hours, allowing the body to absorb it in a more consistent manner.
    • Pulmatrix (NASDAQ:PULM): FY GAAP EPS of -$4.98.
    • Revenue of $0.15M (-55.9% Y/Y)
    • Press Release
    • Under Priority Review status, the FDA has accepted AbbVie's (NYSE:ABBV) marketing application seeking approval for JAK1 inhibitor upadacitinib for the treatment of adult patients with moderate-to-severe rheumatoid arthritis (RA). The agency's action date is in Q3.
    • The company's application in Europe is under EMA review.
    • Shares are up a fraction premarket.
    • The FDA has granted Fast Track Designation to Cerecor's (NASDAQ:CERC) CERC-801, an ultra-pure, oral formulation of D-galactose for the treatment of Phosphoglucomutase 1 (PGM1) deficiency, also known as PGM1-CDG.
    • Fast Track provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
    • Shares are up 4% premarket.
    • Medtronic (NYSE:MDT) has received Breakthrough Device designation from the FDA for its Personalized Closed Loop (PCL) insulin pump system, currently in development for diabetes management.
    • The PCL technology is designed to automate insulin delivery in a way that is real-time, personalized and adapts to the user.
    • Breakthrough Device status provides more intensive guidance on development from agency and accelerated review of the marketing application.
    • Shares are up 2% premarket.
    • Thinly traded nano cap Motif Bio (NASDAQ:MTFB) slumps 17% premarket on increase volume in reaction to its working capital situation.
    • In order to avoid an default on its loan with Hercules Capital, it has amended the agreement, making a $7M early repayment to be followed by another $0.5M in either 90 days or when it raises at least $2M in new capital (whichever is earlier).
    • The company now has ~$3M in cash and will have to raise new funds in the near term.
    • Shares plummeted last week after it received a CRL from the FDA regarding its marketing application for iclaprim for ABSSSI citing the need for additional data on liver toxicity.
    • The FDA has accepted for review Pfenex's (NYSEMKT:PFNX) NDA for PF708, a Forteo therapeutic equivalent in the treatment of osteoporosis.
    • The FDA set target goal date is October 7. Additionally, FDA is not planning to hold an advisory committee meeting to discuss the NDA.
    • Forteo is approved and marketed by Eli Lilly and Company.
    • CytoDyn (OTCQB:CYDY) will conduct 8 pre-clinical studies on melanoma cancer, pancreatic, breast, prostate, colon, lung, liver and stomach cancer.
    • As part of CytoDyn’s recent acquisition of ProstaGene, it received control of a laboratory that operates under the guidance of Dr. Pestell.
    • CytoDyn estimates the total cost of pre-clinical studies for these 8 cancers is ~$1.5M.
    • MEDNAX (NYSE:MD) is proposing to issue $200M aggregate amount of 6.250% senior notes due 2027 in a private offering.
    • The Notes will be issued as additional notes under an indenture, dated as of December 8, 2015, pursuant to which the Company previously issued $500M 6.250% senior notes due 2027 (the “Existing Notes”) and will have identical terms to the Existing Notes, other than the issue date and the issue price.
    • Net proceeds will be used to repay a portion of the indebtedness outstanding under its senior unsecured revolving credit facility.
    • Alkermes plc (NASDAQ:ALKS) will collaborate with Clovis Oncology (NASDAQ:CLVS) to evaluate the combination of ALKS 4230, an engineered interleukin-2 (IL-2) variant immunotherapy, with Clovis' PARP inhibitor Rubraca (rucaparib) and tyrosine kinase inhibitor lucitanib, in preclinical models across a range of tumor types.
    • The companies will share costs and contribute their respective compounds.
    • The FDA has granted orphan drug designation (ODD) to Biohaven Pharmaceuticals' (NYSE:BHVN) verdiperstat (previously BHV-3241), a myeloperoxidase inhibitor, for the treatment of multiple system atrophy (MSA).
    • Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
    • The FDA has accepted Nabriva Therapeutics' (NASDAQ:NBRV) New Drug Applications (NDAs) for both the intravenous (IV) and oral formulations of lefamulin, a semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia (CABP).
    • Both applications have been granted priority review and the PDUFA goal date is August 19. In addition to priority review, lefamulin has been granted Qualified Infectious Disease Product and Fast Track designations by the FDA.
    • Shares are up 4% premarket.
    • NeoGenomics (NEO) Q4 results: Revenues: $76.5M (+24.6%); Clinical testing: $65.9M (+23.2%); Pharma services: $10.6M (+32.5%).
    • Net Income: $0.4M (-78.9%); Non-GAAP Net Income: $5.5M (+71.9%); EPS: $0.00; Non-GAAP EPS: $0.06 (+50.0%); CF Ops: $44.8M (+148.9%).
    • 2019 Guidance: Revenue: $379M - 395M; Net income: ($3M) - $3M; non-GAAP EBITDA: $49M - 53M.
    • Previously: NeoGenomics beats by $0.02, beats on revenue (Feb. 19)
    • The FDA has accepted under Priority Review two applications from Roche (OTCQX:RHHBY) unit Genentech for new cancer therapies:
    • Entrectinib for adult and pediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1-positive non-small cell lung cancer (NSCLC). The agency's action date is August 18.
    • Antibody-drug conjugate polatuzumab vedotin, combined with Rituxan (rituximab) plus bendamustine, patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The agency's action date is August 19.
    • Recro Pharma (REPH) Q4 results: Revenues: $17.8M (-6.3%).
    • Net Loss: ($41.3M) (-71.4%); Non-GAAP Net Loss: ($12.5M) (-4.2%); Loss Per Share: ($1.92) (-52.4%); Non-GAAP Loss Per Share: ($0.58) (+7.9%).
    • Financial Guidance: CDMO division revenue: ~$80M.
    • Shares are up a fraction premarket.
    • Previously: Recro Pharma beats by $0.17, beats on revenue (Feb. 19)
    • The positive Phase 3 data-stoked rally in Intercept Pharmaceuticals is rippling out to certain other NASH players.
    • CymaBay Therapeutics (NASDAQ:CBAY) (+2%): seladelpar.
    • Viking Therapeutics (NASDAQ:VKTX) (+3%): VK2809.
    • Madrigal Pharmaceuticals (NASDAQ:MDGL) (+1%): MGL-3196.
    • Galectin Therapeutics (NASDAQ:GALT) (+1%): GR-MD-02.
    • Spark Therapeutics (ONCE) FY results: Revenues: $64.7M.
    • Net Loss: ($78.8M) (+68.9%); Loss Per Share: ($2.11) (+72.3%); Quick Assets: $520.2M (+14.7%).
    • Shares are down 2% premarket.
    • Previously: Spark Therapeutics EPS of -$2.11 (Feb. 19)
    • InspireMD (NSPR) Q4 results: Revenues: $0.82M (-1.2%).
    • Net Loss: ($2.2M) (+60.0%); Loss Per Share: ($0.05) (+99.3%); Quick Assets: $9.4M (+154.1%).
    • The Company is on-track to submit U.S. IDE in mid-2019.
    • Shares are down 3% premarket.
    • Previously: InspireMD reports Q4 results (Feb. 19)
    • Intercept Pharmaceuticals (NASDAQ:ICPT) is up 23% premarket on light volume following its announcement of positive results from a Phase 3 clinical trial, REGENERATE, evaluating obeticholic acid (OCA) in patients with liver fibrosis (scarring) due to nonalcoholic steatohepatitis (NASH).
    • The study met one co-primary endpoint, a statistically significant proportion of patients achieving at least one stage improvement in fibrosis with no worsening of NASH at month 18 (p=0.0002), but failed to meet the other, the proportion of patients achieving NASH resolution with no worsening of liver fibrosis. The FDA agreed that only one endpoint needed to be met in order to be judged successful.
    • The data will be presented at the European Association for the Study of the Liver (EASL): International Liver Congress in Vienna April 10 - 14.
    • The company plans to file a U.S. marketing application in H2.
    • Spark Therapeutics (NASDAQ:ONCE): FY EPS of -$2.11 may not be comparable to consensus of -$1.46.
    • Revenue of $64.73M (+436.3% Y/Y) misses by $16.21M.
    • Shares -2.41% PM.
    • Press Release
    • GMP Securities cuts to Hold from Buy, noting a combination of high investor expectations, but an unclear path to profitability.
    • CGC -1.2% premarket
    • Sage Therapeutics (SAGE) Q4 results: Revenues: $0.3M.
    • Net Loss: ($158.4M); Loss Per Share: ($3.38) (-93.1%); Quick Assets: $922.8M (+77.9%).
    • Financial Guidance: Sage now anticipates that its existing cash, cash equivalents and marketable securities, and estimated product sales of ZULRESSO, will enable the Company to fund its operating expenses and capital expenditure requirements into 2H 2020.
    • Previously: Sage Therapeutics misses by $0.41 (Feb. 19)
    • Results from a Phase 3 clinical trial, KEYNOTE-426, evaluating Merck's (NYSE:MRK) Keytruda (pembrolizumab), combined with Pfizer's (NYSE:PFE) Inlyta (axitinib), in first-line renal cell carcinoma  (RCC) showed the combo's superiority to Pfizer's Sutent (sunitinib). The data were presented at the ASCO GU Cancer Symposium in San Francisco.
    • The combination significantly improved overall survival (OS) compared to Sutent with 47% less risk of death (hazard ratio = 0.53).
    • The overall response rate (ORR) was 59.3% for Keytruda + Inlyta compared to 35.7% for Sutent (p<0.0001), including a 5.8% complete response rate (versus 1.9% for Sutent). Median duration of response was 15.2 months.
    • The company's U.S. marketing application seeking approval for the combo in first-line RCC is under FDA review with an action date of June 20.