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

Down In The Dumps

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

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

Stocks In Focus

Insmed Wins FDA Panel Backing

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

After The Market Close

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