Clovis $CLVS has always been considered an acquisition target with a big list of potential buyers which includes Eli Lilly $LLY, Merck & Co $MRK and Roche, Janney said in an interview to Bloomberg. The stock gained sharply on Tuesday as earlier during the day Gilead $GILD said that it was looking for deals in cancer treatments. Clovis's PDUFA date for ovarian cancer drug rucaparib is Feb. 23, 2017.

Mast Therapeutics $MSTX shares got hammered in after-hours trading on Tuesday after the drug-maker announced that its Phase 3 EPIC trial of vepoloxamer, meant for curing individuals with sickle cell disease experiencing vaso-occlusive crisis, could not meet its primary endpoints. The company said, “We are exceedingly disappointed with these top-line results... These analyses are limited to just top-line data, so in the coming weeks the Company intends to review the full data set from EPIC. In addition, we plan to perform an interim analysis of the ongoing heart failure trial of vepoloxamer”.
I had given a bearish call on MSTX earlier this year after the company’s surprise secondary offering. I had also raised concerns about the continuing delay in the release of the Phase 3 EPIC trial results. With not much to fall back on, I believe investors who didn't get out when I warned might have to take a hit on this one and exit.

Mirna Therapeutics Suspends Early-Stage Trial of Lead Candidate; Shares Tumble- Shares of normally thinly traded Mirna Therapeutics $MIRN saw increased trading volume even as shares slumped more than 25% after it announced voluntary suspension of enrollment and dosing in its Phase 1 study on a lead candidate MRX34. The drug-maker took the decision after it found five immune related severe adverse events in subjects given with MRX34. It said that now it will not be starting a translational medicine study of the lead candidate in melanoma patients, which was planned later this year. Meanwhile, the company is evaluating the data of trails and will discuss the outcome with its advisors and FDA.

Aimmune Top-Line Data on Phase 3 Study of Lead Candidate AR101 Likely in Q4 2017- Aimmune Therapeutics $AIMT announced on Tuesday that it completed its North America enrollment target for its Phase 3 study, PALISADE, evaluating lead product candidate AR101 for the desensitization of patients allergy to peanuts. Final enrollment would be 425 - 450, compared to the original target of 350. Enrollment in Europe should be completed by year end. Top-line data should be available in Q4 2017.Enrollment in another study, RAMSES, intended to build real-world experience with AR101, will start in Q1 2017.

Shire Unenthusiastic with Myelofibrosis Candidate after Mixed Results- Shire plc $SHPG looks unenthusiastic to continue with its study on myelofibrosis candidate pacritinib following mixed results in a mid-stage study. Earlier in February, it received a set-back after FDA imposed hold on full clinical trial due to excessive deaths in the enrollment group caused by intracranial hemorrhage, cardiac failure and cardiac arrest.

Amgen's Repatha Meets Success in late-stage coronary plaque imaging study- A Phase 3 clinical trial, GLAGOV, evaluating the capability of Amgen's $AMGN anti-cholesterol med Repatha (evolocumab) to alter the buildup of artery plaque met its primary and secondary endpoints. Detailed outcome will be discussed on Tuesday, November 15 at the American Heart Association Scientific Sessions in New Orleans, LA.

Synthetic Biologics completes enrollment in mid-stage study of ribaxamase for prevention of C. diff infection- Synthetic Biologics $SYN announced that ensuing the conclusion of its earlier planned interim analysis by an independent Interim Analysis Committee (IAC), enrollment has been finalized in its Phase 2b randomized, placebo-controlled, proof-of-concept clinical trial evaluating SYN-004 (ribaxamase) for the prevention of Clostridium difficile (C. diff) infection. Top-line data should be available in Q1 2017.

Teva, Regeneron Aims to Target Lilly/Pfizer Pain Treatment- Israeli drug-maker Teva Pharmaceutical $TEVA Industries and Regeneron Pharmaceuticals Inc $REGN announced on Tuesday that they intend to jointly develop Regeneron’’s experimental new type of pain treatment. If the clinical trials are successful and approved by the regulators, they would jointly market the medicine, according to a Reuters’ report. The injectable treatment, branded as fasinumab, blocks Nerve Growth Factor (NGF), a protein responsible for transmitting pain signals. In the press release, the drug-makers said that its new mechanism of action could be a non-addictive a substitute to opioids. Currently, late-stage clinical trials are being conducted for evaluating its effectiveness to cure osteoarthritis pain and mid-stage studies for chronic low back pain. Rival drug-makers Elli Lilly $LLY and Pfizer Inc. $PFE are planning to get regulatory approval for a similar drug, tanezumab, by 2018.

BioLineRx Starts Mid-stage Study on Pancreatic Cancer - BioLineRx $BLRX started a Phase 2a study, COMBAT, evaluating lead product candidate BL-8040 and Merck's $MRK KEYTRUDA (pembrolizumab) for curing metastatic pancreatic adenocarcinoma. The study involves 30 subjects. It would be an open-label, single-arm trail for assessing the efficacy of the drug. The trial is being conducted under the companies' January immunotherapy collaboration. According to, the expected trial completion date is December 2018.

The European Medicines Agency (EMA) accepted Bristol-Myers Squibb's $BMY type II variation application looking for approval of the use of Opdivo (nivolumab) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults who fail to respond to prior platinum-based therapy.Opdivo is currently approved in the EU for the treatment of melanoma, non-small cell lung cancer and renal cell carcinoma, which is a kidney cancer.

The FDA agreed to review Puma Biotechnology’s $PBYI New Drug Application (NDA) seeking approval of neratinib (PB272) for the extended adjuvant cure of patients with early-stage HER2+ breast cancer who have been before treated with adjuvant trastuzumab-based therapy (Roche's Herceptin).The data backing-up the filing was generated in the Phase 3 ExteNET study which gave evidence that treating patients with neratinib resulted in a 33% reduction in the risk of invasive disease recurrence or death versus placebo.The specific FDA action date (PDUFA) was not given, but should be in July 2017.

Lannett Company $LCI said on Tuesday that it got an approval from the FDA for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, meant to cure opioid addiction, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg.

Shares of Sarepta Therapeutics $SRPT jumped sharply on Tuesday after USPTO’s Patent Trial and Appeals Board (PTAB) favored Sarepta in its interference proceeding against BioMarin Pharmaceutical (BMRN) linked to patents covering “expn skipping”. A year ago, the PTAB ruling sided with BioMarin's claims on the use of exon 51 antisense oligonucleotides to cure Duchenne muscular dystrophy (DMD) specified in its U.S. Patent Application No. 14/198,992, a decision Sarepta challenged. BioMarin licensed the patent from Academisch Ziekenhuis Leiden.

Allergan $AGN underscored its commitment to the NASH space with its second acquisition in a day. It bought a privately held Akarna Therapeutics for $50M in upfront cash plus unspecified milestones. Akarna develops small molecule drugs for curing inflammatory and fibrotic diseases. Its lead product candidate is AKN-083, a preclinical-stage FXR agonist in development for the treatment of NASH. FXR (farnesoid X receptor) is a master regulator of carbohydrate and lipid metabolism, bile-acid homeostasis, inflammation and fibrosis.

AbbVie (NYSE: ABBV) entered in an agreement with privately held Sweden-based BioArctic AB to develop and commercialize BioArctic’s portfolio of candidates directed against alpha-synuclein intended to cure Parkinson’s disease and other complications. The Swedish drug-maker’s technology platform focuses on neurodegenerative diseases and other CNS disorders caused by misfolded proteins including Alzheimer's disease, Lewy body dementia, ALS, Huntington's disease and transthyretin amyloidosis. Terms of the agreement were not revealed.

Aquinox Pharmaceuticals $AQXP priced its public offering of 5.35M shares of common stock at $12.25. Underwriters’ over-allotment is an additional 802.5K shares. Closing date is September 23. Monday’s close was $12.68.

Fulgent Genetics is set to make an IPO of 4.6M shares of common stock at $12 - 14.The Temple City, CA-based molecular diagnostics company gives genetic testing services mainly to hospitals and medical institutions. The healthcare company said it has advanced proprietary technology platform, including gene probes, advanced database algorithms, adaptive learning software and laboratory management systems, which allows it to provide services at low-cost. FY2016 (6 mo.)($M): Revenue: 7.4 (+96.6%); Gross Profit: 4.7 (+100.3%); Operating Expenses: 4.3 (+263.9%); Net Loss: (5.1) (-999%); Cash Flow Ops: (0.0) (+97.6%).

Cesca Therapeutics $KOOL announced fiscal fourth-quarter results on Tuesday. Revenue came at $2.98 million, which was 19.5% lower, year-over-year and missing its target by $0.02 million. Net loss stood at $3.7 million.

Palatin Tech $PTN FY16 results: Revenues: nil; R&D Expense: $43.1M (+75.2%); SG&A: $6.2M (+8.8%); Operating Loss: ($49.3M) (-185.0%); Net Loss: ($51.7M) (-192.1%); Loss Per Share: ($0.33) (-120.0%); Quick Assets: $9.4M (-65.6%). The company did not give any guidance.

Bellerophon Therapeutics $BLPH announced a planned management transition by end of the year. While Jonathan Peacock will retain his position as chairman of the board, Fabian Tenenbaum, the current financial and chief business officer, is set to become as the CEO.

Multinational drug giant, GlaxoSmithKline $GSK appointed Emma Walmsley, a consumer goods veteran as it new CEO. She would take over the reins from Sir Andrew Witty in March. Ms. Walmsley currently oversees GSK’s consumer healthcare unit. Prior to joining GSK in 2010, Ms. Walmsley worked in French cosmetic company, L’Oréal for 17 years in marketing and general management divisions.