The Daily Biotech Pulse: Setback For Bristol-Myers Squibb, Gemphire Explodes, Lilly's Nasal Low Blood Sugar Drug

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 24)

• Acasti Pharma Inc ACST
• Cardiovascular Systems Inc CSII
• Grifols SA - ADR ADR Class B GRFS
• Masimo Corporation MASI
• VolitionRX Ltd VNRX
• Edwards Lifesciences Corp EW(reported a beat-and-raise second quarter)
• Haemonetics Corporation HAE

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 24)

• Autolus Therapeutics Ltd – ADR AUTL
• Dynavax Technologies Corporation DVAX
• Five Prime Therapeutics Inc FPRX
• Foamix Pharmaceuticals Ltd FOMX
• GENFIT S A/ADR GNFT
• ContraVir Pharmaceuticals Inc HEPA
• Innoviva Inc INVA
• Invivo Therapeutics Holdings Corp NVIV
• Kaleido Biosciences Inc KLDO
• Marinus Pharmaceuticals Inc MRNS
• Neovasc Inc NVCN
• Organogenesis Holdings Inc ORGO
• Pluristem Therapeutics Inc. PSTI(announced 1-for-10 reverse stock split)
• Regulus Therapeutics Inc RGLS(FDA imposed partial clinical hold on its kidney disease drug)
• Surface Oncology Inc SURF
• Tetraphase Pharmaceuticals Inc TTPH
• Wave Life Sciences Ltd WVE

Stocks In Focus

FDA Approves Lilly's Nasally-Administered Low Blood Sugar Drug

Eli Lilly And Co LLY said the FDA has approved its Baqsimi, the first and only nasally administered glucagon to treat severe hypoglycemia in a single, fixed, 3mg dose. The U.S. list price for the drug is $280.80 for a one pack and $561.60 for a two-pack. The company expects to make Baqsimi available in the U.S. pharmacies within a month.

Bristol-Myers Squibb's Opdivo Flunks Late-Stage Lung Cancer Study

Bristol-Myers Squibb Co BMY announced that Part 2 of the Phase 3 CheckMate-227 trial that is evaluating its Opdivo plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer, regardless of PD-L1 status, did not meet the primary endpoint of overall survival.

However, the company said the Part 1a of the Phase 3 CheckMate-227 trial met the co-primary endpoint of overall survival, with Opdivo plus low-dose Yervoy showing superior benefit versus chemotherapy in first-line NSCLC patients, whose tumor express PD-L1 of 1% or less.

The stock slipped 3.48% to $41.51 in after-hours trading.

Aeglea's Rare Genetic Disorder Drug Gets Breakthrough Designation

Aeglea Bio Therapeutics Inc AGLE said the FDA granted Breakthrough Therapy Designation to its lead investigational therapy pegzilarginase, for the treatment of Arginase 1 Deficiency, a rare progressive disease presenting in early childhood that results in severe complications and early mortality.

The stock rose 4.62% to $7.48 in after-hours trading.

Cara Prices 5.5M Common Stock Offering At $23/Share

Cara Therapeutics Inc CARA priced its underwritten public offering of 5.5 million shares at $23 per share. The company expects to raise gross proceeds of $126.5 million from the offering.

The stock fell 9.48% to $23.78 in after-hours trading.

Zafgen Gets FDA Backing For Animal Study Of Diabetes Drug

Zafgen Inc ZFGN reached an agreement with the FDA on an in vivo animal study design and protocol to establish relevant safety margins for ZGN-1061, its investigational MetAP2 inhibitor that is being evaluated for Type 2 diabetes. The FDA had placed a clinical hold on ZGN-1061 last November, citing cardiovascular safety problems. The company expects to release top-line data from the in vivo animal study by the end of 2019.

The stock added 9% to $1.09 in after-hours trading.

Regenxbio, Neurimmune Collaborate To Develop Vectorized Antibodies For Neurodegenerative Diseases

Regenxbio Inc RGNX and Swiss biotech Neurimmune announced an exclusive license development and commercialization agreement to discover and develop AAV gene therapies using NAV Vectors to deliver human antibodies against targets implicated in chronic neurodegenerative diseases, including tauopathies.

The stock added 1.32% to $51.28 in after-hours trading.

Gemphire Announces Reverse Merger With NeuroBo

Gemphire Therapeutics Inc GEMP announced a reverse merger with privately-held NeuroBo Pharma, which is a clinical-stage biotech focusing on therapies for neurodegenerative diseases, in an all-stock deal. Upon completion of the merger, Gemphire plans to change its name to NeuroBo Pharma and its ticker symbol to NRBO.

On a pro forma basis, based on the number of Gemphire shares to be issued for the merger, its shareholders will own 4.06% of the combined company and NeuroBo shareholders will own the rest.

Gemphire also announced an out-licensing agreement with Beijing SL Pharmaceutical to advance its pipeline asset gemcabene into the Chinese market, receiving an upfront gross payment of $2.5 million in the process.

The stock jumped 37.49% to 99 cents in after-hours trading.

Earnings

Roche Holdings AG Basel ADR RHHBY reported 9% growth in first-half sales at constant exchange rates and a 13 percent increase in core earnings per share. The company raised its full-year sales growth outlook.

Anika Therapeutics Inc ANIK reported above-consensus earnings and revenues for the second quarter.

The stock rallied 10.22% to $44.99 in after-hours trading.

LeMaitre Vascular Inc LMAT reported 9% revenue growth to $29.5 million and earnings per share of 23 cents per share, ahead of the 21-cent per share consensus. The company issued above-consensus revenue guidance and it raised its bottom-line guidance.

The stock rose 6.22% to $34.50 in after-hours trading.

On The Radar

Earnings

Alkermes Plc ALKS (before the market open)
Baxter International Inc BAX (before the market open)
Bristol-Myers Squibb Co BMY (before the market open)
West Pharmaceutical Services Inc. WST (before the market open)
Novocure Ltd NVCR (before the market open)
ResMed Inc. RMD (after the market close)
Merit Medical Systems, Inc. MMSI (after the market close)

IPOs

Castle Biosciences, a genomic testing company for diagnosing dermatological cancers, priced its upsized offering of 4 million shares at $16 per share, the upper bound of the estimated price range. The company had initially planned to offer 3.33 million shares. Castle's shares will be listed on the Nasdaq under the ticker symbol CSTL.