The Daily Biotech Pulse: FDA Panel Backs Insmed, Eidos' Maiden Earnings, Paratek Awaits Adcom Verdict

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling the Peaks

(Stocks hitting 52-week highs on Aug. 7)

• Akcea Therapeutics Inc (NASDAQ:AKCA)(reacted to Q2 earnings reported after the close Monday)
• AstraZeneca plc (ADR) (NYSE:AZN)
• BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)(NASDAQ:ONCE)'s 27 percent slump on data regarding its Hemophilia A treatment candidate)
• Bio-Rad Laboratories, Inc.(NYSE:BIO)
• BIO-TECHNE Corp (NASDAQ:TECH)(reported above-consensus results for its Q4)
• CAS Medical Systems Inc (NASDAQ:CASM)
• Eli Lilly And Co (NYSE:LLY)
• Endo International PLC (NASDAQ:ENDP)
• Haemonetics Corporation (NYSE:HAE)
• Ligand Pharmaceuticals Inc. (NASDAQ:LGND)(reacted to a beat-and-raise quarter)
• Medtronic PLC (NYSE:MDT)
• Merck & Co., Inc. (NYSE:MRK)
• Pfizer Inc. (NYSE:PFE)
• Qiagen NV (NYSE:QGEN)
• Vanda Pharmaceuticals Inc. (NASDAQ:VNDA)
• Zoetis Inc (NYSE:ZTS)

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 7)

• Aerpio Pharmaceuticals Inc (NASDAQ:ARPO)
• Arcus Biosciences Inc (NYSE:RCUS)(reacted to Q2 results released after the market close, Monday)
• Avadel Pharmaceuticals PLC (ADR) (NASDAQ:AVDL)(reported below-consensus bottom-line results for Q2)
• Bellerophon Therapeutics Inc (NASDAQ:BLPH)(reacted to interim results from the Phase 3 trial of its pulmonary arterial hypertension drug candidate)
• Citius Pharmaceuticals Inc (NASDAQ:CTXR)
• DENTSPLY SIRONA Inc (NASDAQ:XRAY)(lowered its FY18 guidance)
• Enzo Biochem, Inc. (NYSE:ENZ)
• Flex Pharma Inc (NASDAQ:FLKS)
• Gemphire Therapeutics Inc (NASDAQ:GEMP)(reacted to an extension to the timeframe for lifting of the partial hold on its cholesterol treatment candidate gemcabene)
• OHR Pharmaceutical Inc (NASDAQ:OHRP)
• Oramed Pharmaceuticals, Inc. (NASDAQ:ORMP)
• Osiris Therapeutics, Inc. (NASDAQ:OSIR)
• Pulmatrix Inc (NASDAQ:PULM)
• Puma Biotechnology Inc (NASDAQ:PBYI)
• Reshape Lifesciences Inc (NASDAQ:RSLS)
• Vascular Biogenics Ltd (NASDAQ:VBLT)

Stocks In Focus

Insmed Wins FDA Panel Backing

Insmed Incorporated (NASDAQ:INSM) announced FDA's Antimicrobial Drugs Advisory Committee, which met to discuss the safety and efficacy of its amikacin liposome inhalation suspension (ALIS) to treat non-tuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC), voted 12 to 2 in favor of the therapy.

The company said the committee also voted in favor of the surrogate endpoint of sputum culture conversion used in the Phase 3 COVERT study reasonably predicting clinical benefit.

However, the committee voted against the safety and effectiveness of ALIS in the broadest population of adult patients with NTM lung disease caused by MAC.

The PDUFA date for ALIS is set for Sept. 28.

The stock rallied 4.64 percent to $25.50 in after-hours trading.

ReShape, Progenics, Medpace Price Offerings

ReShape Lifesciences priced its previously announced underwritten public offering at $0.085 per share. The company expects to raise gross proceeds of $1.06 million from the offering, while the offering is expected to close on or about Aug. 10. All shares offered are to be sold by the company.

The penny stock tumbled 45.24 percent to $0.18 in after-hours trading.

Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) said it has priced its underwritten public offering of 9.09 million of its shares at $8.25 per share, with the gross proceeds from the offering estimated at $75 million. All the shares offered are to be sold by the company.

The stock fell 6.94 percent to $8.31 in after-hours trading.

Medpace Holdings Inc (NASDAQ:MEDP)'s underwritten public offering of 4.5 million shares was priced at $55 per share. The shares offered are being sold by selling shareholders.

The stock slipped 2.01 percent to $55.19 in after-hours trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates

Stocks Reacting to Earnings

Eidos Therapeutics Inc (NASDAQ:EIDX) reported a wider loss of $1.38 per share for its Q2 compared to the consensus estimate for a loss of 23 cents per share. The company said it's financed adequately to continue developing its AG10 as a disease modifying therapy for transthyretin amyloidosis.

The stock climbed 9.03 percent to $16.55 in after-hours trading.

Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) said its adjusted EPS of $3.49 for Q2 beat the consensus estimate of $3.23. Revenues rose 27 percent to $500.48 million. The company also raised its FY18 Xyrem sales guidance to $1.35 billion to $1.38 billion.

The stock slipped 6.61 percent to $168 in after-hours trading.

HTG Molecular Diagnostics Inc (NASDAQ:HTGM) reported a loss of 14 cents per share for its Q2 compared to a loss of 19 cents per share estimated by analysts. Revenues rose from $1.76 million to $4.91 million. The company also affirmed its full-year revenue guidance of $21 million to $25 million

The stock soared 12.20 percent to $3.22 in after-hours trading.

Prothena Corporation PLC (NASDAQ:PRTA) reported a sharp drop in its revenues from $26.8 million in Q2'17 to $0.3 million in Q2. The net loss per share widened from 46 cents to $1.50 per share.

The stock fell 7.67 percent to $13.24 in after-hours trading.

Inogen Inc (NASDAQ:INGN)'s Q2 EPS rose from 38 cents to 65 cents, ahead of the 44 cents per share consensus estimate. Revenues rose 51.6 percent to $97.2 million. The company raised its full-year revenue and earnings guidance.

The stock added 5.97 percent to $226 in after-hours trading.

FibroGen Inc (NASDAQ:FGEN) said its Q2 loss narrowed to 28 cents, thanks to a milestone payment for an upcoming Japan NDA submission. Analyst had expected a loss of 59 cents per share for the quarter.

The stock moved up 6.43 percent to $67 in after-hours trading.

PTC Therapeutics, Inc. (NASDAQ:PTCT) reported Q2 revenues of $68.7 million, up 43 percent year-over-year. The loss per share narrowed from 44 cents to 21 cents, while analysts had forecast a loss of 29 cents.

The stock advanced 5.25 percent to $40.30 in after-hours trading.

On The Radar

Adcom Meeting

The Antimicrobial Drugs Advisory Committee is also scheduled to meet to discuss the NDAs for omadacycline tablets and omadacycline injection submitted by Paratek Pharmaceuticals Inc (NASDAQ:PRTK). The candidate is being considered for treating community-acquired bacterial pneumonia as well as for acute bacterial skin and skin structure infections.

Earnings

Before the Market Open

• Mylan NV (NASDAQ:MYL)
• Neos Therapeutics Inc (NASDAQ:NEOS) Q2 EPS $(0.52) Misses $(0.44) Estimate, Sales $11.363M Miss $12.1M Estimate
• Horizon Pharma PLC (NASDAQ:HZNP)
• Regenxbio Inc (NASDAQ:RGNX) Q2 EPS $0.30 May Not Compare To $1.23 Estimate, Sales $40M May Not Compare To $100M Estimate
• Nektar Therapeutics (NASDAQ:NKTR)
• Endo International PLC (NASDAQ:ENDP) Q2 EPS $0.76 Beats $0.54 Estimate, Sales $714.696M Beat $678.35M Estimate
• Eagle Test Systems (NASDAQ:EGLT) Q2 EPS $(0.22) Beats $(0.28) Estimate, Sales $7.4M Miss $7.99M Estimate
• Axsome Therapeutics Inc (NASDAQ:AXSM)
• Clearside Biomedical Inc (NASDAQ:CLSD) Q2 EPS $(0.65) Misses $(0.58) Estimate

After The Market Close

• Sangamo Therapeutics Inc (NASDAQ:SGMO)
• Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL)
• Sonoma Pharmaceuticals Inc (NASDAQ:SNOA)
• ZIOPHARM Oncology Inc. (NASDAQ:ZIOP)
• Insys Therapeutics Inc (NASDAQ:INSY)
• Pfenex Inc (NYSE:PFNX)
• Akebia Therapeutics Inc (NASDAQ:AKBA)
• Foamix Pharmaceuticals Ltd (NASDAQ:FOMX)
• BIOLASE Inc (NASDAQ:BIOL)
• Sarepta Therapeutics Inc (NASDAQ:SRPT)
• Celldex Therapeutics, Inc. (NASDAQ:CLDX)
• TRACON Pharmaceuticals Inc (NASDAQ:TCON)
• Natera Inc (NASDAQ:NTRA)
• ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD)
• Arcadia Biosciences Inc (NASDAQ:RKDA)
• Coherus Biosciences Inc (NASDAQ:CHRS)
• PDL BioPharma Inc (NASDAQ:PDLI)
• CytomX Therapeutics Inc (NASDAQ:CTMX)
• Chembio Diagnostics Inc (NASDAQ:CEMI)
• Collegium Pharmaceutical Inc (NASDAQ:COLL)
• Depomed Inc (NASDAQ:DEPO)
• G1 Therapeutics Inc (NASDAQ:GTHX)