The Daily Biotech Pulse: Acorda To Trim Jobs, GlaxoSmithKline Gets FDA Nod, Edward Lifesciences Posts Q3 Beat-And-Raise

The following is a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks that hit 52-week highs Oct. 23.)

• Applied Therapeutics Inc APLT
• AVITA MED LTD/S ADR RCEL
• Bio-Rad Laboratories, Inc. BIO
• Eli Lilly And Co LLY (reported below-consensus revenue for the third quarter)
• ESSA Pharma Inc EPIX
• LeMaitre Vascular Inc LMAT

Down In The Dumps

(Biotech stocks that hit 52-week lows Oct. 23.)

• Adaptive Biotechnologies Corp ADPT
• Bellicum Pharmaceuticals Inc BLCM
• Castle Biosciences Inc CSTL
• Chimerix Inc CMRX
• Gritstone Oncology Inc GRTS
• KemPharm Inc KMPH
• MacroGenics Inc MGNX (announced lukewarm results for breast cancer drug trial)
• TapImmune Inc. MRKR
• OpGen Inc OPGN (announced a common stock offering)
• Orgenesis Inc ORGS
• Precision BioSciences Inc DTIL
• Selecta Biosciences Inc SELB
• TRACON Pharmaceuticals Inc TCON
• Trinity Biotech plc TRIB

Stocks In Focus

TherapeuticsMD Pre-Announces Q3 Revenue 

TherapeuticsMD Inc TXMD pre-announced third-quarter results and said it expects net revenue from its prescription vitamin business of $2.5 million to $2.6 million and net revenue from sales of its FDA-approved medicines — Imvexxy, Bijuva and Annovera — of $5.32 million to $5.7 million.

Based on the updated guidance issued Wednesday, TherapeuticsMD's total third-quarter net revenue could arrive in a range of $7.82-$8.3 million. This is within the company's prior total net revenue guidance range of $6.75-$9 million, but below the Street expectation of $8.41 million.

Imvexxy revenue is projected at $4.5 million-$4.8 million, up from $3.1 million in the June quarter, and Bijuva net revenue is expected to increase from $134,000 to $450,000 to $500,000.

Annovera, which was commercially launched in August, is expected to generate revenue of $375,000 to $400,000.

The company announced an underwritten public offering of 22 million shares of its common stock.

The stock fell 13.32% to $3.19 in after-hours trading.

Progenics Activist Investor Accuses Company Of Misleading Investors

Activist investor Velan Capital released a statement accusing Progenics Pharmaceuticals, Inc. PGNX of resorting to desperate tactics to mislead shareholders about the firm's intentions and its nominees' plan to deliver long-term value at the company.

Progenics announced a deal in early October to be bought by Lantheus Holdings Inc LNTH in an all-stock deal. Velan, which has a substantial stake in Progenics, raised objections to the transaction on the grounds that the company is selling for a massive discount,

Velan said in the late Wednesday statement that communications from both Progenics and Lantheus contained false and misleading claims.

Progenics stock rose 9.56% to $5.27 in after-hours trading.

See also: Biotech Stock On The Radar: Assessing Mirati's Oncology Franchise With An Eye On Multiple Readouts

Novartis Gets Label Update For Higher Dose of Cosentyx Approved In Europe

Novartis AG NVS said the European Commission has approved a label update for the up-titration of psoriasis drug Cosentyx to 300mg for patients with active ankylosing spondylitis.

OpGen Prices Underwritten Offering

OpGen priced its previously announced underwritten public offering of an aggregate of 4.7 million units at $2 per unit. Each unit comprises one share of common stock and one common warrant to purchase one share of common stock. The company expects to receive gross proceeds of $9.4 million from the offering.

After sliding nearly 38% in Wednesday's regular session in the wake of the common stock offering, OpGen shares lost 6.28% to $3.43 in after-hours trading.

Acorda To Reduce Workforce By 25%

Acorda Therapeutics Inc ACOR announced a corporate restructuring to trim costs and focus its resources on the launch of Inbrija. The restructuring includes elimination of 25% of the workforce, with the job cuts to take place immediately and end by the first quarter of 2020.

Beginning in 2020, the company said it expects the job cuts to bring in annualized cost savings of about $21 million, while it estimates pre-tax charges of $8 million related to the actions.

The company lowered its opex forecast for 2019 and provided opex guidance for 2020.

Acorda also pre-announced third-quarter Inbrija net revenue of $4.9 million and Ampyra net revenue of $37.6 million, lower than $137.8 million in the year-ago quarter. Inbrija was made commercially available in February.

The stock fell 2.03% to $2.65 in after-hours trading.

GlaxoSmithKline's Zejula Gets Label Expansion In The U.S.

GlaxoSmithKline plc GSK said the FDA approved Zejula for an expanded indication of treating advanced ovarian, fallopian tube or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status.

Myriad Genetics, Inc. MYGN announced FDA approval for MyChoice CDx for use as a companion diagnostic by health care professionals to identify women with advanced ovarian cancer who are candidates for Zejula in the late-line treatment setting

Myriad Genetics stock added 1.23% to $32 in after-hours trading.

Earnings

Edwards Lifesciences Corp EW reported above-consensus third-quarter adjusted earnings per share and its sales rose 21% to $1.1 billion. The company raised its full-year guidance.

The stock rallied 5.92% to $238.50 in after-hours trading.

Varian Medical Systems, Inc. VAR reported in-line third-quarter non-GAAP earnings per share and 10% revenue growth to $878.9 million.

The stock gained 5.83% to $124.25 in after-hours trading.

On The Radar

PDUFA Dates

Melinta Therapeutics Inc MLNT and Ligand Pharmaceuticals Inc. LGND await the FDA's decision on a label expansion for Baxdella in community-acquired bacterial pneumonia.

Clinical Trial Readouts

Syros Pharmaceuticals Inc SYRS is due to present updated Phase 2 data for SY-1425 in acute myeloid leukemia/myelodysplastic syndrome at the 5th International Conference Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment conference being held Oct. 24-26 in Estoril, Portugal.

Earnings

Baxter International Inc BAX (before the market open)

Integra Lifesciences Holdings Corp IART (before the market open)

West Pharmaceutical Services Inc. WST (before the market open)

Genocea Biosciences Inc GNCA (before the market open)

Anika Therapeutics Inc ANIK (after the close)

ResMed Inc. RMD (after the close)

Illumina, Inc. ILMN (after the close)

Gilead Sciences, Inc. GILD (after the close)

Related Link: The Week Ahead In Biotech: Earnings Trickle In, While Glaxo, Melinta, Foamix And Eton Await FDA Verdict