The Daily Biotech Pulse: Acadia Schizophrenia Drug Fails, Viveve Plummets, Eisai Gets Breakthrough Therapy Designation

Here’s a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week highs on July 22)

• Acasti Pharma Inc (NASDAQ: ACST)
• Apellis Pharmaceuticals Inc (NASDAQ: APLS)
• Arcturus Therapeutics Ltd (NASDAQ: ARCT)
• GALAPAGOS NV/S ADR (NASDAQ: GLPG)
• Kodiak Sciences Inc (NASDAQ: KOD)
• Krystal Biotech Inc (NASDAQ: KRYS)
• Ra Pharmaceuticals Inc (NASDAQ: RARX)
• Flex Pharma (NASDAQ: SLRX)(announced merger with Salarius Pharma and renamed as Salarius)
• Veracyte Inc (NASDAQ: VCYT)

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 22)

• Abeona Therapeutics Inc (NASDAQ: ABEO)
• Adamis Pharmaceuticals Corp (NASDAQ: ADMP)
• Aduro BioTech Inc (NASDAQ: ADRO)
• Advaxis, Inc. (NASDAQ: ADXS)(announced upsized stock offering)
• Aerie Pharmaceuticals Inc (NASDAQ: AERI)
• Aileron Therapeutics Inc (NASDAQ: ALRN)
• Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)
• BENITEC BIOPHAR/S ADR (NASDAQ: BNTC)
• Bristol-Myers Squibb Co (NYSE: BMY)
• Celldex Therapeutics, Inc. (NASDAQ: CLDX)
• Collegium Pharmaceutical Inc (NASDAQ: COLL)
• Dynavax Technologies Corporation (NASDAQ: DVAX)
• Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)
• Endo International PLC (NASDAQ: ENDP)
• Evolent Health Inc (NYSE: EVH)
• Gamida Cell Ltd (NASDAQ: GMDA)
• GENFIT S A/ADR (NASDAQ: GNFT)
• Heat Biologics Inc (NASDAQ: HTBX)
• Hemispherx BioPharma, Inc (NYSE: HEB)
• Hoth Therapeutics Inc (NASDAQ: HOTH)
• Ideaya Biosciences Inc (NASDAQ: IDYA)
• Intec Pharma Ltd (NASDAQ: NTEC) (a late-stage trial of a drug combo the company is developing for Parkinson’s disease did not meet the primary endpoint)
• Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
• Kaleido Biosciences Inc (NASDAQ: KLDO)
• Kindred Biosciences Inc (NASDAQ: KIN)
• Madrigal Pharmaceuticals Inc (NASDAQ: MDGL)
• MEI Pharma Inc (NASDAQ: MEIP)
• Myovant Sciences Ltd (NYSE: MYOV)
• Neovasc Inc (NASDAQ: NVCN)
• Neuralstem, Inc. (NASDAQ: CUR)
• Nuvectra Corp (NASDAQ: NVTR)
• Organogenesis Holdings Inc (NASDAQ: ORGO)
• Proteostasis Therapeutics Inc (NASDAQ: PTI)
• Puma Biotechnology Inc (NASDAQ: PBYI)
• Psychemedics Corp. (NASDAQ: PMD)
• Strongbridge Biopharma plc (NASDAQ: SBBP)
• Tcr2 Therapeutics Inc (NASDAQ: TCRR)
• Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
• TrovaGene Inc (NASDAQ: TROV)
• United Therapeutics Corporation (NASDAQ: UTHR)
• Urogen Pharma Ltd (NASDAQ: URGN)
• Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)(received communication from the FDA regarding deficiencies in the sNDA for Hetlioz to treat jet lag disorder)
• Xenetic Biosciences Inc (NASDAQ: XBIO)
• Zafgen Inc (NASDAQ: ZFGN)

Stocks In Focus

ACADIA’s Schizophrenia Drug Flunks a Late-stage Study

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) said the top-line results from a Phase 3 study dubbed ENHANCE, which evaluated pimavanserin as an adjunctive treatment in adult schizophrenia patients with persistent inadequate response to their current antipsychotic therapy, showed the trial did not achieve statistical significance on the primary endpoint. However, the company noted a consistent trend in improvement of psychotic symptoms.

The stock fell 15.63% to $21.91 in after-hours trading.

Sanofi Gets Exclusive Rights to OTC Tamiflu In The U.S.

Sanofi SA (NASDAQ: SNY) said it has signed an agreement with Roche Holdings AG Basel ADR (OTC: RHHBY) for the exclusive over-the-counter rights to Tamiflu for the prevention and treatment of influenza in the U.S. Tamiflu is currently sold in the U.S. by Roche’s Genentech as a prescription medication.

Under the agreement, Sanofi will be responsible for negotiating with the FDA regarding the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the U.S.

Eisai Gets Breakthrough Therapy Designation For Drug to Treat Liver Cancer

Eisai Co., Ltd (OTC: ESALY) said the FDA has granted Breakthrough Therapy Designation for Lenvima, its orally available kinase inhibitor, in combination with Merck & Co., Inc. (NYSE: MRK)’s Keytruda,for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment.

Ra Pharma To Sell Shares

Ra Pharmaceuticals said it intends to sell, subject to market conditions, $100 million worth of its shares in an underwritten public offering. All the shares are to be sold by the company. The company intends to use the net proceeds to fund pre-commercialization activities for zilucoplan, extended release formulation of zilucoplan, clinical development of pipeline programs, and for working capital and other general corporate purposes.

Viveve To Explore Strategic Alternatves; Stress Urinary Incontinence Treatment Fails to Meet Primary Endpoint

Viveve Medical Inc (NASDAQ: VIVE) said it has initiated a strategic analysis of its business in a bid to preserve cash and to explore financing and strategic alternatives to maximize value. The company also said its LIBERATE-International trial to evaluate the safety and efficacy of its proprietary cryogen-cooled monopolar radiofrequency technology for the improvement of stress urinary incontinence in women did not show greater improvement compared with the control group.

Viveve also announced a transition of its business model to renting system versus selling under a capital equipment model.

The stock plummeted 61.51% to 15.7 cents in after-hours trading.

On The Radar

Clinical Trial Readouts

Myovant is due to release results from the Phase 3 LIBERTY 2 study that evaluated its once-daily relugolix combo therapy in women with uterine fibroids and heavy menstrual bleeding. The company will also release results from a separate bioequivalence study comparing single-tablet relugolix combo therapy with two-tablet regimen used in the LIBERTY clinical program.

Earnings

Biogen Inc (NASDAQ: BIIB) (before the market open)

Edwards Lifesciences Corp (NYSE: EW) (after the market close)

Quest Diagnostics Inc (NYSE: DGX) (after the market close)