Benzinga's Daily Biotech Pulse: Portola Receives FDA Nod, Mallinckrodt Gets Thumbs Down

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 May 3)

• ABIOMED, Inc. ABMD (reported better-than-expected Q4 results)
• AveXis Inc AVXS (reported Q1 results and provided corporate update and details on upcoming milestones)
• Enanta Pharmaceuticals Inc ENTA
• Integra Lifesciences Holdings Corp IART

Down In The Dumps

(Stocks hitting 52-week lows on May 3)

• Akorn, Inc. AKRX (has been on a slide since Wednesday following Fresenius SE's allegation that it submitted fraudulent data to the FDA regarding its antibiotic azithromycin)
• Altimmune Inc ALT
• Anika Therapeutics Inc ANIK (announced Q1 miss and product recall)
• Gemphire Therapeutics Inc GEMP
• IntelliPharmaCeutics Intl Inc (USA) IPCI
• Mallinckrodt PLC MNK
• Regeneron Pharmaceuticals Inc REGN(reported Q1 EPS beat, In-line revenues; lowered Sanofi collaboration revenue guidance for FY18)
• RXi Pharmaceuticals Corp RXII
• Titan Pharmaceuticals, Inc. common stock TTNP
• VanEck Vectors Biotech ETF BBH

Stocks In Focus

FDA Greenlights Portola's Bleeding Control Drug

Portola Pharmaceuticals Inc PTLA announced the FDA approved its Andexanet alfa, a factor Xa inhibitor reversal agent. The company said it's the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The company said it will initiate a trial in 2019 to meet post-marketing requirement, the results of which are due in 2023.

The company expects to launch the product under an Early Supply Program with a Generation 1 product in June, while a commercial launch is planned in early 2019, contingent on FDA's vetting of the generation 2 manufacturing process.

The stock rose 26 percent to $42.66 in Friday's pre-market session.

FDA Panel Votes Against Mallinckrodt's Jaundice Drug

A joint meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee, which discussed Mallinckrodt PLC MNK unit InfaCare Pharma's NDA for stannsoporfin injection, intramuscular formulation, ruled by a 21-3 vote that the risk-benefit profile of it doesn't support approval for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

The company said following the FDA panel vote, it is evaluating alternatives for the development program.

See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates

Adamas Reports Q1 Beat

Adamas Pharmaceuticals Inc ADMS reported a narrower-than-expected Q1 loss of $1.35 per share, and revenues also exceeded estimates. The stock rallied 5.54 percent to $31.41 in after hours.

Twin Executive Departures at Adverum

Adverum Biotechnologies Inc ADVM shares slumped 9.37 percent to $5.755 after the company announced CEO Dr. Amber Salzman is stepping down, effective May 3. The company also said its chief medical officer Athena Countouriotis will depart, effective May 11.

TESARO Misses On Both Top- and Bottom-line

TESARO reported a Q1 net loss of $2.98 per share compared to the $2.70 loss expected by analysts. Revenues of $50.17 million also trailed the consensus estimate of $56.93 million. The stock slid 2.81 percent to $47 in after hours Thursday.

Aratana Posts Q1 Revenue Miss

Aratana Therapeutics Inc PETX shares lost 5.94 percent to $4.75 after it reported a Q1 loss of 19 cents per share, narrower than the 20 cents loss expected. Revenues were below consensus.

Akcea Posts Above-consensus Q1 Revenues, Announces Extension of PDUFA Date

Akcea Therapeutics Inc AKCA announced the FDA extended the PDUFA date for its tegsedi to Oct. 6, 2018, as the agency requires additional time to look at the responses presented to the standard requests. The company also reported above-consensus FQ1 revenues, while it posted a loss for the quarter.

The stock slumped 5.7 percent to $22.60.

Other Stocks That Reacted to Earnings

• TherapeuticsMD Inc TXMD – Up 1.59 percent
• Sarepta Therapeutics Inc SRPT – Down 2.5 percent
• NewLink Genetics Corp NLNK – Up 2.67 percent
• Spectrum Pharmaceuticals, Inc. SPPI – Up 4.3 percent
• Alnylam Pharmaceuticals, Inc. ALNY – Up 1.35 percent

On The Radar

The following companies report earnings on Friday:

• ACADIA Pharmaceuticals Inc. ACAD Q1 EPS $(0.44) Beats $(0.56) Estimate, Sales $48.868M Beat $47.06M Estimate
• Achaogen Inc AKAO Q1 EPS $(1.06) Misses $(0.89) Estimate, Sales $2.1M Beat $1.14M Estimate
• Agios Pharmaceuticals, Inc. AGIO Q1 EPS $(1.63), Inline, Sales $8.762M Miss $10.6M Estimate
• Celgene Corporation CELG Q1 EPS $2.05 Beats $1.96 Estimate, Sales $3.531B Beat $3.46B Estimate
• ImmunoGen, Inc. IMGN Q1 EPS $(0.30) Misses $(0.24) Estimate, Sales $19.815M Beat $15.04M Estimate
• Ionis Pharmaceuticals Inc IONS Q1 EPS $(0.01) Beats $(0.04) Estimate, Sales $144.41M Miss $145.29M Estimate