(Announcing November Discounts. Only for the month of November, the first 57 (100-43) new subscribers will get a huge discount to my popular biotech service. Click this link to find out how much you can save.)
Focus Ticker: Relypsa
Relypsa (RLYP) has had a very interesting past one month. In October, the company's NDA for Patiromer for Oral Suspension (brand name Veltassa) for the treatment of hyperkalemia was approved by the FDA. Despite the approval, RLYP shares tumbled. This is because the FDA approval came with a boxed warning. I had given a call on RLYP shortly after the stock tumbled to subscribers on my RTTAS service. I had noted that the sell-off was an overreaction as the boxed warning was not due to any safety issue. The call was given when RLYP was at $11. On Monday, the stock closed at $19.90. The question is whether there is further upside in RLYP.
As I noted earlier, the boxed warning for Veltassa was not due to any safety issue but rather due to the fact that the drug binds other oral drugs thereby decreasing their absorption and reducing their effectiveness. The boxed warning says that other oral medications should be administered at least 6 hours before or 6 hours after Veltassa is taken. Now this is an inconvenience. But given that Veltassa is better than the current standard of care, I don't expect this inconvenience to have a negative impact on Veltassa sales.
In the U.S. alone, around 2.1 million patients suffer from high level of potassium, according to Liana Moussatos of Wedbush Pacgrow Lifesciences. Veltassa is expected to be a blockbuster drug. Based on the peak sales potential, RLYP is still trading at just under 1x sales. I believe there is significant upside in RLYP despite the gains it has made in the past three weeks. Remember that a week before Veltassa's approval, RLYP had been trading at around $19.50. So the stock in the past three weeks has only regained the levels it was trading at before the approval. The approval itself and Veltassa's sales potential is not yet priced into the stock. With the acquisition of ZS Pharma recently, RLYP is also seen as a takeover target. ZS Pharma's ZS-9 is also being developed as a treatment for hyperkalemia.
Sector News
Mallinckrodt Tumbles on Citron Tweet- Mallinckrodt (MNK) shares fell more than 17% in late trading on Monday after Citron Research called the company a far worse offender of the reimbursement system than Valeant. The tweet from Citron said that there was more to follow on MNK. Mallinckrodt also suffered a setback as a pilot study run by the company assessing H.P. Acthar Gel in patients with persistently active Systemic Lupus Erythematosus ('SLE) on corticosteroid therapy failed to meet its primary endpoint.
Agios Pharma Falls as AG-120 Phase I Data Fails to Impress Investors- Agios Pharmaceuticals (AGIO) shares fell more than 14% on Monday after the company announced data from dose-escalation Phase I study of AG-120 in patients with IDH1 mutant positive advanced solid tumors. The data was presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.
Sanofi and Regeneron Announce Positive Results from Pivotal Phase III Study of Sarilumab- Sanofi (SNY) and Regeneron (REGN) announced positive results from a pivotal Phase III study of sarilumab, which is an investigational, human antibody against the IL-6 receptor. The Phase III study met both its co-primary endpoints of improvements in signs and symptoms of rheumatoid arthritis ('RA) and improvements in physical function. The study also met secondary efficacy endpoints.
Teva Pharmaceutical's SD-809 Granted Breakthrough Therapy by FDA- Teva Pharmaceutical (TEVA) announced that the FDA has granted its SD-809 a Breakthrough Therapy Designation for the treatment of patients with moderate to severe tardive dyskinesia. The condition affects around half a million people in the U.S. alone.
Loxo Oncology's LOXO-101 Shows Promise in Phase I Trial- Loxo Oncology (LOXO) announced that its LOXO-101 showed promising clinical activity and safety in Phase I trial. David Hong, MD, deputy chair and associate professor in the Department of Investigational Therapeutics at The University of Texas MD Anderson Cancer Center in Houston, said that the efficacy being seen for LOXO-101 at a well-tolerated dose is as compelling as any he has seen in Phase I.
Amgen's Biosimilar Shows Clinical Equivalence to Humira- Amgen (AMGN) announced the presentation of detailed findings from a head-to-head Phase III study that compared the safety, efficacy and immunogenicity of its biosimiar candidate AB 501 with Humira (adalimumab) in patient with moderate-to-severe rheumatoid arthritis ('RA). The Phase III study met the primary endpoint of achievement of 20% or greater improvement in ACR assessment at week 24. The findings were presented in an oral presentation at the 2015 American College of Rheumatology ('ACR)/Association of Rheumatology Health Professionals ('ARHP) Annual Meeting in San Francisco.
Coherus and Baxalta's CHS-0214 Meets Primary Endpoint in Phase III Study- Coherus BioSciences (CHRS) and Baxalta (BXLT) announced that their CHS-0214 met its primary endpoints in a Phase III study. The ongoing 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Amgen's Enbrel in patients with moderate-to-severe chronic plaque psoriasis.
MannKind Enters into Stock Purchase Agreements, Reports Q3 Results- MannKind (MNKD) has entered into a series of stock purchase agreements to sell up to an aggregate of 50,000,000 shares of its common stock in a registered direct offering to selected investment funds in Israel that hold securities included within certain stock indexes of the Tel Aviv Stock Exchange. As per the stock purchase agreements, the shares of common stock will be sold at a price per share equal to 97% of the closing price of MNKD's common stock on the Tel Aviv Stock Exchange on November 12, 2015. MannKind also reported its third-quarter results on Monday, posting a loss of $0.08 per share. The company's loss was a penny more than the consensus forecast.
Amarin Comments on New Data from CHERRY Study- Amarin (AMRN) commented on new data from the CHERRY study. The data supports the hypothesis that highly purified EPA drug therapy may reduce residual risk in coronary heart disease ('CHD) patients already on lipid-lowering statin therapy. The CHERRY study is investigating whether coronary plaque regression and stabilization are reinforced by further administration of EPA to pitavastatin therapy in patients.
RedHill's RIZAPORT Granted Marketing Authorization in Germany- RedHill Biopharma (RDHL) and IntelGenx announced that Germany's BfArM granted marketing authorization to RIZAPORT 5 mg and 10 mg for the treatment of acute migraines. RIZAPORT is an oral thin film formulation of rizatriptan benzoate.
Deals
Amgen Looking for Deals- According to a report in the Financial Times, Amgen is looking for potential acquisitions. Amgen has not made any major acquisition since 2013 even as M&A activity in the biotech sector has heated up. The FT, citing an investor who met with Amgen's management team, has reported that the company is telling shareholders to get prepared for an acquisition.
Ignyta Acquires Exclusive Rights to Taladegib- Ignyta (RXDX) has acquired the exclusive license of worldwide rights to Eli Lilly's (LLY) taladegib oncology development program in exchange for an upfront payment of $2 million in cash and 1.2 million shares of RXDX common stock. RXDX has also licensed exclusive worldwide rights to the topical formulation of taladegib.
Janssen Signs License Agreement with Hanmi Pharmaceuticals- Janssen (JNJ) and South Korea-based Hanmi Pharmaceuticals have entered into an exclusive license agreement for the development and commercialization of oxyntomodulin-based therapies including Hanmi's HM12525A, which is expected to enter Phase II studies in 2016. HM12525A is a novel biologic GLP-1/Glucagon dual receptor agonist to treat diabetes and obesity.
Secondary Offerings
Mirati Therapeutics Files Form S-3- Mirati Therapeutics (MRTX) has filed a Form S-3 with the U.S. Securities and Exchange Commission ('SEC). As per the filing, the company may offer up to $300 million of any combination of securities described in the prospectus from time to time.
Versartis Files Form S-3- Versartis (VSAR) filed a Form S-3 with the SEC under which the company may from time to time, offer and sell up to $200 million of any combination of its common stock, preferred stock, debt securities or warrants described in the prospectus, either individually or in combination with other securities.
IPOs
No IPOs to report.
Earnings
Neovasc (NVCN) reported a loss of C$0.15 per share in its third quarter. The company reported revenue of C$3.24 million for the quarter, down 24.1% on a year-over-year basis.
Epizyme (EPZM) reported a loss of $0.56 per share for the third quarter, beating consensus forecast by 3 cents. The company's revenue for the quarter was $0.36 million, down 95.6% on a year-over-year basis. Revenue for the quarter missed consensus forecast by $5.06 million.
AVEO Pharmaceuticals (AVEO) reported earnings of $0.14 per share for the third quarter, beating consensus forecast by 23 cents. The company's revenue for the quarter was $15.16 million, beating consensus forecast by $14.96 million.
Novavax (NVAX) reported a loss of $0.12 per share for the third quarter, missing consensus forecast by 3 cents. The company's revenue for the quarter was $6.53 million, down 20.5% on a year-over-year basis. NVAX's revenue missed consensus forecast by $4.5 million.
Pozen (POZN) reported a loss of $0.25 per share for the third quarter, beating consensus forecast by a penny. The company's revenue for the quarter was $5.82 million, down 22.8% on a year-over-year basis. Revenue beat consensus forecast by $0.62 million.
Inovio Pharmaceuticals (INO) reported third-quarter earnings of $0.07 per share, beating consensus forecast by 3 cents. The company's revenue for the quarter was $24.18 million, in-line with the consensus forecast.
Isis Pharmaceuticals (ISIS) reported a loss of $0.30 per share for the third quarter, beating consensus forecast by a penny. The company reported revenue of $49.12 million, missing consensus forecast by $3.81 million.
Intercept Pharma (ICPT) reported a loss of $2.10 per share for the third quarter, beating consensus forecast by 64 cents. The company's revenue for the quarter was $0.45 million, beating consensus forecast by $0.03 million.
Curis (CRIS) reported a loss of $0.04 per share for the third quarter, beating consensus forecast by 4 cents. The company reported revenue of $2.04 million for the quarter, missing consensus forecast by $0.78 million.
Impax Lab (IPXL) reported earnings of $0.40 per share for the third quarter, beating consensus forecast by a penny. The company's revenue for the quarter was $221.1 million, up 39.9% on a year-over-year basis. Revenue for the quarter beat consensus forecast by $6.65 million.
Alnylam Pharmaceuticals (ALNY) reported a loss of $0.91 per share for the third quarter, which is in-line with the consensus forecast. The company's revenue for the quarter was $6.32 million, missing consensus forecast by $1.23 million.
RedHill reported a loss of $0.04 per share in the third quarter. The company's revenue for the quarter was $1,000, missing consensus forecast by $19,000.
BioDelivery (BDSI) reported a loss of $0.39 per share for the third quarter, missing consensus forecast by 6 cents. The company's revenue for the quarter was $1.24 million, down 31.9% on a year-over-year basis. BDSI's revenue missed consensus forecast by $0.36 million.
Derma Sciences (DSCI) reported a loss of $0.35 per share for the third quarter, beating consensus forecast by 8 cents. The company reported revenue of $22.17 million, missing consensus forecast by $0.14 million.
Progenics Pharmaceuticals (PGNX) reported a loss of $0.14 per share for the third quarter, missing consensus forecast by a penny. The company reported revenue of $1.4 million for the quarter, missing consensus forecast by $0.95 million.
Karyopharm Therapeutics (KPTI) reported a loss of $0.85 per share for the third quarter, beating consensus forecast by 2 cents. The company's revenue for the quarter was $0.08 million, beating consensus forecast by $0.01 million.
Ignyta reported a loss of $0.49 per share for the third quarter, beating consensus forecast by 11 cents. The company ended the quarter with cash, cash equivalents and available-for-sale securities totaling $1631.1 million on its balance sheet.
TG Therapeutics (TGTX) reported a loss of $0.28 per share for the third quarter, beating consensus forecast by 6 cents. The company's revenue for the quarter was $0.04 million, in-line with the consensus forecast.
BioSpecifics Tech (BSTC) reported earnings of $0.39 per share for the third quarter. The company's revenue for the quarter was $6.3 million, up 57.1% on a year-over-year basis.
Fortress Biotech (FBIO) reported a loss of $0.46 per share for the third quarter. The company's revenue for the quarter was $0.03 million.
Galmed (GLMD) reported a loss of $0.23 per share for the third quarter, beating consensus forecast by 6 cents. The company ended the quarter with current assets, which comprised mainly of cash and cash equivalents and marketable securities, of $25.7 million on its balance sheet.
BioTime (BTX) reported a loss of $0.18 per share for the third quarter. The company's revenue for the quarter was $2.31 million, up 94.1% on a year-over-year basis.
GenVec (GNVC) reported a loss of $0.09 per share for the third quarter, beating consensus forecast by 2 cents. The company's revenue for the quarter was $0.19 million, down 24% on a year-over-year basis. GNVC's revenue beat consensus forecast by $0.04 million.
Galectin Therapeutics (GALT) reported a loss of $0.26 per share for the third quarter, missing consensus forecast by 6 cents. The company ended the quarter with $21.3 million in non-restricted cash and cash equivalents on its balance sheet.
Synergy Pharma (SGYP) reported a loss of $0.23 per share for the third quarter, beating consensus forecast by 5 cents. The company ended the quarter with $142 million in cash, cash equivalents and available-for-sale securities on its balance sheet.
Pluristem Therapeutics (PSTI) reported a loss of $0.07 per share for the first quarter, beating consensus forecast by 2 cents. The company's revenue for the quarter was $0.1 million, in-line with the consensus forecast.
Verastem (VSTM) reported a loss of $0.42 per share for the third quarter, beating consensus forecast by 2 cents. The company ended the quarter with cash, cash equivalents and investments of $120.5 million on its balance sheet.
Akebia (AKBA) reported a loss of $0.68 per share for the third quarter, missing consensus forecast by 16 cents. The company ended the quarter with cash, cash equivalents and available for sale securities of $157.5 million on its balance sheet.
Tonix Pharmaceuticals (TNXP) reported a loss of $0.72 per share for the third quarter, missing consensus forecast by 10 cents. The company ended the quarter with $55 million in cash, cash equivalents and marketable securities on its balance sheet.
Kindred Biosciences (KIN) reported a loss of $0.36 per share for the third quarter, beating consensus forecast by 8 cents. The company ended the quarter with $83.6 million in cash, cash equivalents and short-term investments on its balance sheet.
Ocata Therapeutics (OCAT) reported a loss of $0.09 per share for the third quarter, beating consensus forecast by 9 cents. The company reported revenue of $0.08 million for the quarter, up 100% on a year-over-year basis.
Neuralstem (CUR) reported a loss of $0.06 per share for the third quarter, beating consensus forecast by a penny. The company's revenue for the quarter was $2,500.
Repros Therapeutics (RPRX) reported a loss of $0.27 per share for the third quarter, beating consensus forecast by 2 cents. The company's revenue for the quarter was $1,000.
Merrimack Pharmaceuticals (MACK) reported a loss of $0.38 per share for the third quarter, beating consensus forecast by 2 cents. The company reported revenue of $16.4 million, down 41.4% on a year-over-year basis. MACK's revenue beat consensus forecast by $2.36 million.
Rockwell Medical (RMTI) reported a loss of $0.05 per share for the third quarter, missing consensus forecast by 3 cents. The company's revenue for the quarter was $14.4 million, missing consensus forecast by $0.53 million.
Blueprint Medicines (BPMC) reported a loss of $0.47 per share for the third quarter, beating consensus forecast by 6 cents. The company's revenue for the quarter was $3.42 million, beating consensus forecast by $2.05 million.
Cara Therapeutics (CARA) reported a loss of $0.19 per share for the third quarter, beating consensus forecast by 8 cents. The company's revenue for the quarter was $2.44 million, beating consensus forecast by $0.67 million.
Flexion Therapeutics (FLXN) reported a loss of $0.52 per share for the third quarter, beating consensus forecast by 8 cents. The company ended the quarter with $132.2 million in cash, cash equivalents and marketable securities on its balance sheet.
Jazz Pharmaceuticals (JAZZ) reported earnings of $2.52 per share for the third quarter, missing consensus forecast by 4 cents. The company had revenue of $340.9 million, missing consensus forecast by $7.25 million.
Halozyme Therapeutics (HALO) reported a loss of $0.19 per share for the third quarter, missing consensus forecast by 3 cents. The company's revenue for the quarter was $20.8 million, missing consensus forecast by $3.21 million.
Zogenix (ZGNX) reported a loss of $0.65 per share for the third quarter, beating consensus forecast by 9 cents. The company's revenue for the quarter was $9.1 million, beating consensus forecast by $3.2 million.
Asterias Biotherapeutics (AST) reported a loss of $0.09 per share, beating consensus forecast by 2 cents. The company's revenue for the quarter was $1.42 million, beating consensus forecast by $0.98 million.
Revance Therapeutics (RVNC) reported a loss of $0.81 per share for the third quarter, beating consensus forecast by 20 cents. The company's revenue for the quarter was $0.08 million, missing consensus forecast $0.01 million.
Depomed (DEPO) reported earnings of $0.33 per share for the third quarter, beating consensus forecast by 14 cents. The company's revenue for the quarter was $105 million, beating consensus forecast by $3.36 million.
Galena Biopharma (GALE) reported a loss of $0.11 per share for the third quarter, missing consensus forecast by 4 cents. The company ended the quarter with cash and cash equivalents of $34.8 million on its balance sheet.
Organovo Holdings (ONVO) reported a loss of $0.12 per share for the second quarter, missing consensus forecast by 2 cents. The company's revenue for the quarter was $0.3 million, in-line with the consensus forecast.
Opko Health (OPK) reported earnings of $0.25 per share for the third quarter. The company's revenue for the quarter was $143 million, beating consensus forecast by $10.01 million.
Aegerion Pharmaceuticals (AEGR) reported a loss of $0.34 per share for the third quarter, beating consensus forecast by 8 cents. The company reported revenue of $67.3 million, beating consensus forecast by $7.71 million.
SciClone Pharmaceuticals (SCLN) reported earnings of $0.26 per share for the third quarter, beating consensus forecast by 14 cents. The company's revenue for the quarter was $42.9 million, beating consensus forecast by $2.29 million.
Zosano Pharma (ZSAN) reported a loss of $0.72 per share for the third quarter, missing consensus forecast by 11 cents. The company ended the quarter with cash, cash equivalents and marketable securities totaling $43.9 million on its balance sheet.
ChemoCentryx (CCXI) reported a loss of $0.26 per share for the third quarter, beating consensus forecast by 3 cents. The company ended the quarter with $85.2 million in cash, cash equivalents and investments on its balance sheet.
Ligand Pharmaceuticals (LGND) reported earnings of $0.56 per share for the third quarter, beating consensus forecast by 14 cents. The company's revenue for the quarter was $17.7 million, beating consensus forecast by $6.46 million.
Intrexon (XON) reported a loss of $0.34 per share for the third quarter, missing consensus forecast by 13 cents. The company's revenue for the quarter was $53.4 million, beating consensus forecast by $12.56 million.
PTC Therapeutics (PTCT) reported a loss of $1.27 per share for the third quarter, missing consensus forecast by 12 cents. The company reported revenue of $9.78 million for the quarter, missing consensus forecast by $0.1 million.
Portola Pharmaceuticals (PTLA) reported a loss of $1.05 per share for the third quarter, beating consensus forecast by 19 cents. The company's revenue for the quarter was $2.91 million, beating consensus forecast $0.46 million.
Pain Therapeutics (PTIE) reported a loss of $0.08 per share for the third quarter. The company ended the quarter with $34.9 million in cash and investments on its balance sheet.
Avalanche Biotechnologies (AAVL) reported a loss of $0.55 per share for the third quarter, missing consensus forecast by 13 cents. The company's revenue for the quarter was $0.95 million, beating consensus forecast by $0.59 million.
Puma Biotechnology (PBYI) reported a loss of $1.87 per share for the third quarter, missing consensus forecast by 3 cents. The company ended the quarter with $23.6 million in cash and cash equivalents and $224.2 million in marketable securities on its balance sheet.
Calithera Biosciences (OTC:CALA) reported a loss of $0.49 per share for the third quarter, beating consensus forecast by 3 cents. The company ended the quarter with $81.9 million in cash, cash equivalents and investments on its balance sheet.
Ultragenyx Pharmaceutical (RARE) reported a loss of $1.03 per share for the third quarter, missing consensus forecast by 16 cents. The company ended the quarter with $581.9 million in cash, cash equivalents and investments on its balance sheet.
Catalyst Pharmaceutical (CPRX) reported a loss of $0.06 per share for the third quarter, beating consensus forecast by a penny.
Omeros (OMER) reported a loss of $0.53 per share for the third quarter, missing consensus forecast by 6 cents. The company's revenue for the quarter was $3.3 million, missing consensus forecast by $3.9 million.
Bellicum Pharmaceuticals (OTCPK:BLCM) reported a loss of $0.51 per share for the third quarter, missing consensus forecast by 13 cents. The company's revenue for the quarter was $0.06 million, missing consensus forecast by $0.12 million.
Protalix BioTherapeutics (PLX) reported a loss of $0.04 per share for the third quarter, beating consensus forecast by 4 cents. The company's revenue for the quarter was $4.3 million, missing consensus forecast by $0.7 million.
Insider Transactions
Neuralstem Insider Sells- Karl Johe, Chief Scientific Officer at Neuralstem sold 25,000 shares at $1.18. The total value of the transaction was $29,500.
Isis Pharmaceuticals Insider Sells- Frank C. Bennett, SVP, Antisense Research at Isis Pharmaceuticals sold 5,000 shares at $56. The total value of the transaction was $280,000.
Vertex Pharmaceuticals Insider Sells- Stuart A. Arbuckle, EVP/Chief Commercial Officer at Vertex Pharmaceuticals (VRTX) sold 6,264 shares at $123.18. The total value of the transaction was $771,622.
Valeant CEO Sells- Michael J. Pearson, CEO at Valeant Pharmaceuticals (VRX) sold 1,297,399 shares at $78.48. The total value of the transaction was approximately $101.83 million.
Regeneron Insider Sells- Neil Stahl, EVP, Research and Development at Regeneron sold 42,101 shares in two separate transactions. Stahl sold 22,101 shares at $560.05 and 20,000 shares at $563.
Big Movers
NYSE- Valeant Pharmaceuticals was one of the major movers on the NYSE. The stock closed 4.45% higher. Mallinckrodt was the worst performing biotech stock on the NYSE. The stock closed 17% lower.
NASDAQ- Loxo Oncology was one of the best performing biotech stocks on the NASDAQ. The stock closed 19.05% higher. Isis Pharmaceuticals ended the day 12.35% higher. Celldex Therapeutics (CLDX) ended the day 12.27% higher. Anavex Life Sciences (AVXL) ended the day 24.39% lower. Calithera Biosciences ended the day 21.86% lower. Aegerion Pharmaceuticals ended the day 19.80% lower.
NYSEMKT- Actinium Pharmaceuticals (ATNM) was one of the most active stocks on the NYSEMKT. The stock closed 4.35% lower. ATNM rose more than 13% in after-hours trading.
OTC- Amarantus Bioscience (OTC:AMBS) shares ended the day 5.88% lower.
Short Interest Data (As on October 15, 2015)
Subscribe to see.
Top Picks of the Day
Subscribe to see.
Editor's Note: This article covers one or more microcap stocks. Please be aware of the risks associated with these stocks.
