Preliminary data from a Phase 1/2a clinical trial, APPROACH, evaluating Johnson & Johnson's (JNJ -0.6%) investigational HIV-1 vaccine regimen showed encouraging action in 393 healthy volunteers. The results were presented at the 9th IAS Conference on HIV Science in Paris.
The "mosaic"-based vaccine regimen, being developed by Janssen Vaccines & Prevention B.V., induced HIV-1 antibody responses in all (100%) of the volunteers.
Mosaic-based vaccines contain immunogens (antigens that evoke an immune response) created from genes from different HIV subtypes responsible for infections globally. The immunogens are delivered through viral vectors which are combined with other components (such as soluble proteins) to form mosaic-based prime boost vaccine regimens that first prime the immune system before boosting it. The company says this produces a stronger and more sustainable immunity to HIV.
A proof-of-concept Phase 2b study will be launched in southern African countries in Q4/Q1.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions backing the approval of 11 new therapies, including five Orphan Drugs:
Orphan Drug tagged Verkazia (ciclosporin) for the treatment of severe vernal keratoconjunctivitis in children and adolescents. Developed by Finnish drugmaker Santen Oy.
Orphan Drug-tagged Bavencio (avelumab), from Merck Serono Europe Limited, for the treatment of Merkel cell carcinoma.
Orphan Drug-tagged Lutathera (lutetium oxodotreotide), from Advanced Accelerator Applications (AAAP), for the treatment of gastro-entero-pancreatic neurocrine tumors.
Orphan Drug-tagged Rydapt (midostaurin), from Novartis Europharm (NVS -0.5%), for adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive, adults with aggressive systemic mastocytosis or mast cell leukemia.
Orphan Drug-tagged Xermelo (telotristat ethyl), from Ipsen Pharma (OTCPK:IPSEY) for carcinoid syndrome.
Dupixent (dupilumab) for atopic dermatitis - Sanofi-Aventis (SNY -0.6%).
Symtuza (darunavir/cobicistat/emtricitabine) for HIV infection - Johnson & Johnson's Janssen-Cilag International N.V. (JNJ -0.7%).
Tecentriq (atezolizumab) for bladder cancer and non-small lung cancer - Roche (OTCQX:RHHBY).
Three generic meds: Entecavir Accord (entecavir) from Accord Healthcare, Entecavir Mylan (entecavir) from Mylan S.A.S. (MYL -0.9%), both for hepatitis B infection and Lacosamide Accord (lacosamide) for epilepsy from Accord Healthcare.
Final decisions from the European Commission usually take ~60 days.
Diplomat Pharmacy (NYSE:DPLO) initiated with Buy rating and $19.75 (27% upside) price target.
Express Scripts (NASDAQ:ESRX) initiated with Hold rating by Needham.
NeuroDerm (NASDAQ:NDRM) initiated with Buy rating and $47 (52% upside) price target. Shares are up 4% premarket.
TherapeuticsMD (NYSEMKT:TXMD) initiated with Buy rating at Deutsche Bank. Shares up 7% premarket.
Revance Therapeutics (NASDAQ:RVNC) initiated with Overweight rating and $50 (119% upside) price target by Cantor Fitzgerald.
Repligen (NASDAQ:RGEN) initiated with Outperform rating by William Blair.
CRH Medical (NYSEMKT:CRHM) upgraded to Outperform by RBC.
Celgene (NASDAQ:CELG) reiterated at Outperform with a $150 (10% upside) price target.
Cooper Companies (NYSE:COO) downgraded to Sector Weight by Keybanc.
FibroGen (NASDAQ:FGEN) downgraded to Neutral with a $31 (11% downside risk) price target by Goldman Sachs. Shares are down 4% premarket.
Ironwood Pharmaceuticals (NASDAQ:IRWD) downgraded to Neutral with a $19 (11% downside risk) price target by JPMorgan. Shares are down 1% premarket.
Johnson & Johnson (NYSE:JNJ) downgraded to Underweight with a $113 (17% downside risk) price target by Atlantic. Downgraded to Sell with a $110 (19% downside risk) price target by BTIG Research citing a bearish outlook for pharmaceuticals, limited long-term value from Actelion and an overdue mean reversion of valuation compared to its peer group. Shares are down 1% premarket but very light volume.
The European Commission approves Hungarian drugmaker Gedeon Richter's Reagila (cariprazine) for the treatment of schizophrenia. Milan, Italy-based Recordati will commercialize the product in Western Europe, Algeria, Tunisia and Turkey under an August 2016 exclusive license agreement.
Key events are scheduled for the companies listed below next week.
Notable earnings reports: Netflix (NASDAQ:NFLX) on July 17; Bank of America (NYSE:BAC) on July 18; Goldman Sachs (NYSE:GS) on July 18; IBM (NYSE:IBM) on July 18; UnitedHealth (NYSE:UNH) on July 18; Johnson & Johnson (NYSE:JNJ) on July 18; Alcoa (NYSE:AA) on July 19; Morgan Stanley on July 19; American Express (NYSE:AXP) on July 19; Abbott Laboratories (NYSE:ABT) on July 20; Sherwin-Williams (NYSE:SHW) on July 20; Microsoft (NASDAQ:MSFT) on July 20; eBay (NASDAQ:EBAY) on July 20.
Expected IPO pricings: Yogaworks (Pending:YOGA) on July 20; Calyxt (Pending:CLXT) on July 20; TPG Re Finance Trust (Pending:TRTX) on July 20; Federal Street Acquisition (FSACU) on July 20; Kala Pharmaceuticals (Pending:KALA) on July 20; PetIQ (Pending:PETQ) on July 21.
IPO quiet period expirations: Shotspotter (Pending:SSTI) on July 17; Immuron (NASDAQ:IMRN) on July 19; Plymouth Industrial REIT (NYSE:PLYM) on July 19.
Lockup expirations: Fintech Acquisition Corp II (FNTE) on July 19; Keane Group (NYSE:FRAC) on July 19.
Notable annual meetings: Rite Aid (NYSE:RAD) on July 17; Stratasys (NASDAQ:SSYS) on July 18; Constellation Brands (NYSE:STZ) on July 18; SuperValu on July 19; Office Depot on July 20; Perrigo (NASDAQ:PRGO) on July 20.
Special shareholder meetings: OneBeacon Insurance (NYSE:OB) meets July 18; Reynolds American (NYSE:RAI) meets on merger July 19.
Analyst/Investor day: Campbell Soup (NYSE:CPB) on July 19; CarMax (NYSE:KMX) on July 19.
Business update call: Charles Schwab (NYSE:SCHW) on July 21.
FDA watch: Amgen (NASDAQ:AMGN) and Novartis (NYSE:NVS) expected to hear whether erenumab BLA in episodic migraine prophylaxis and chronic migraine prophylaxis is been accepted for review; Eagle Pharmaceuticals (NASDAQ:EGRX) NDA for Ryanodex for treatment of exertional heat stroke has July 23 Pdufa date.
Credit card charge-off data: Coming July 17 from American Express (AXP), BofA (BAC), Citigroup (NYSE:C), Capital One (NYSE:COF), Discover (NYSE:DFS), JPMorgan Chase (NYSE:JPM), Synchrony Financial (NYSE:SYF).
Barron's mentions: Micron (NASDAQ:MU) is headed for a tumble if the chip bubble bursts. Whirlpool (NYSE:WHR) could rise 35% in the coming year if the now-inexpensive company keeps up its capital returns program. In Tech, Cisco (NASDAQ:CSCO) looks undervalued while Verint (NASDAQ:VRNT) seems overvalued.
The FDA approves Johnson & Johnson (NYSE:JNJ) unit Janssen Biotech's TREMFYA (guselkumab) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
TREMFYA is administered as a 100 mg subcutaneous injection every eight weeks following two starter doses at weeks 0 and 4.
Guselkumab is a human monoclonal antibody that binds to interleukin 23 (IL-23), a pro-inflammatory cytokine.
The company says it will work with all stakeholders to ensure that TREMFYA is broadly accessible and affordable for patients and cost competitive with currently available biologics for payers. It plans to offer patients with commercial insurance a co-pay card that limits their out-of-pocket expense to no more than $5 per dose.
The lawsuit by the Oklahoma Attorney General's office targets parent companies and subsidiaries of Johnson & Johnson (JNJ -0.1%), Allergan (AGN -0.2%), Teva Pharmaceutical (TEVA +0.9%) and Purdue Pharma.
Oklahoma follows Mississippi, Ohio and Missouri in suing the drug manufacturers over their opioid marketing and sales practices.
The FDA accepts under Priority Review Johnson & Johnson (NYSE:JNJ) unit Janssen Research & Development's supplemental New Drug Application (sNDA) seeking approval of a 10 mg daily dose of blood thinner XARELTO (rivaroxaban). It is currently approved in a 20 mg strength.
Biotech stocks (NASDAQ:IBB) were bullish again today, surging another 4.1% and extending this week's sector gain to 8% as sentiment emerges that the Trump Administration's attempt to rein in drug prices might not be as harmful as originally feared.
The sentiment got a boost from a NY Times report which cited a draft of an executive order on drug pricing that appears to focus on easing regulatory hurdles for the industry and "largely leaves the drug industry unscathed."
The draft "is a far cry from what [Trump] said on the campaign trail. I don't see anything there that addresses the drug companies getting away with murder, and it appears that is because pharma has captured the process," Patients for Affordable Drugs founder David Mitchell told the Times.