The Daily Biotech Pulse: Heron Pain Drug Review Extended, Disappointment For Teva In Tourette Syndrome Study

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 Feb. 19)

• Adverum Biotechnologies Inc (NASDAQ: ADVM)
• Akebia Therapeutics Inc (NASDAQ: AKBA)
• Anavex Life Sciences Corp (NASDAQ: AVXL)
• Arcus Biosciences Inc (NYSE: RCUS)
• Ascendis Pharma A/S (NASDAQ: ASND)
• AVITA MED LTD/S ADR (NASDAQ: RCEL)(reacted to its half-yearly results)
• Bio-Rad Laboratories, Inc. Class A (NYSE: BIO)
• Calithera Biosciences Inc (NASDAQ: CALA)
• ChemoCentryx Inc (NASDAQ: CCXI)
• Cue Biopharma Inc (NASDAQ: CUE)(said its therapeutic Immuno-STAT platform will be featured in a Merck & Co., Inc.’s (NYSE: MRK) presentation at the Antigen Specific Immune Tolerance Drug Development Summit)
• DexCom, Inc. (NASDAQ: DXCM)
• Fate Therapeutics Inc (NASDAQ: FATE)
• Fulgent Genetics Inc (NASDAQ: FLGT)
• GALAPAGOS NV/S ADR (NASDAQ: GLPG)
• GENMAB A/S/S ADR (NASDAQ: GMAB)(reacted to its quarterly and full-year results)
• Grifols SA – ADR ADR Class B (NASDAQ: GRFS)
• Insulet Corporation (NASDAQ: PODD)
• Intuitive Surgical, Inc. (NASDAQ: ISRG)
• Leap Therapeutics Inc (NASDAQ: LPTX)
• Medpace Holdings Inc (NASDAQ: MEDP)
• Mersana Therapeutics Inc (NASDAQ: MRSN)
• Minerva Neurosciences Inc (NASDAQ: NERV)
• Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
• Nevro Corp (NYSE: NVRO)
• Penumbra Inc (NYSE: PEN)
• Pacira Biosciences Inc (NASDAQ: PCRX)
• PTC Therapeutics, Inc. (NASDAQ: PTCT)
• Quest Diagnostics Inc (NYSE: DGX)
• Repligen Corporation (NASDAQ: RGEN)
• Repro-Med Systems, Inc. (NASDAQ: KRMD)
• ResMed Inc. (NYSE: RMD)
• Soligenix, Inc. (NASDAQ: SNGX)
• Syneos Health Inc (NASDAQ: SYNH)
• Tandem Diabetes Care Inc (NASDAQ: TNDM)
• TELA Bio Inc (NASDAQ: TELA)
• Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
• Viela Bio Inc (NASDAQ: VIE)
• Zai Lab Ltd (NASDAQ: ZLAB)
• Zimmer Biomet Holdings Inc (NYSE: ZBH)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Feb. 19)

• AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)
• CASI Pharmaceuticals Inc (NASDAQ: CASI)
• GenMark Diagnostics, Inc (NASDAQ: GNMK)
• Sellas Life Sciences Group Inc (NASDAQ: SLS)
• Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
• Stealth BioTherapeutics Corp (NASDAQ: MITO)
• SurModics, Inc. (NASDAQ: SRDX)
• Titan Medical Inc. (NASDAQ: TMDI)

Stocks In Focus

FSD Pharma Sells Stake In Cannara Biotech For a 670% Return

FSD Pharma Inc (NASDAQ: HUGE) said it has sold its 12% equity interest in Cannara Biotech to a consortium of buyers for cash proceeds of more than $7.7 million. FSD said the sale fetched it a 670% return on its stake in Cannara.

“Our aim is to scale up to $50 million in disposable cash through monetizing our non-cash assets and raising new capital from institutional and institutional grade investors in the United States and elsewhere,” FSD said.

Tocagen To Merge With Privately-Held Forte Biosciences

Tocagen Inc (NASDAQ: TOCA) announced a reverse merger with privately held Forte Biosciences, which is developing a live biotherapeutic for the treatment of inflammatory skin diseases. Tocagen said the merged company will focus on advancing Forte’s clinical program in inflammatory skin diseases, including atopic dermatitis. Following shareholder approval, the combined company will begin to trade on the Nasdaq under the ticker symbol FBRX.

Hepion’s NASH Drug Shows Anti-fibrotic Activity Across Diseases In In-vitro Studies

Hepion Pharmaceuticals Inc (NASDAQ: HEPA) announced results from in vitro studies, showing its investigational NASH drug CRV431 can decrease production of extracellular matrix molecules, collagen and fibronectin, from fibroblastic cells derived from five different organs.

Over-production of collagen and fibronectin from these cells causes fibrotic scarring of injured organs.

The results, therefore, indicate that CRV431 can exert anti-fibrotic activity across a range of diseases.

In pre-market trading, Hepion shares were rallying 16.88% to $5.54.

Endologix Announces Promotion of Blaise Coleman as CEO

Endologix, Inc. (NASDAQ: ELGX) announced the promotion of CFO Blaise Coleman to the role of CEO, effective March 6. He will also become a member of the board, the company said. The appointment is made in line with the CEO succession plan the company announced in November. The CFO role will be assumed by Mark Bradley, who is currently serving as SVP, Corporate Development & Treasurer.

Separately, the company reported better-than-expected fourth-quarter results.

Shares were advancing 7.07% to 95 cents.

FDA Review Period For Heron’s Post-operative Pain Drug Extended By 3 Months

Heron Therapeutics Inc (NASDAQ: HRTX) said the FDA has extended the review period for the NDA for its investigational post-operative pain drug HTX-011 by up to three months. The new PDUFA date is June 26.

Incidentally, the FDA had issued a CRL to the NDA in May 2019 following which the company had made a resubmission.

The shares slipped 8.13% to $19.90.

Teva’s Tourette Syndrome Drug Flunks Key Registrational Late-stage Trials

Teva Pharmaceutical Industries Ltd (NYSE: TEVA) said the Phase 2/3 ARTISTS 1 and Phase 3 ARTISTS 2 trials that evaluated deutetrabenazine compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome failed to meet the primary endpoint of reduction in motor and phonic tics as assessed by the Total Tic Score of the Yale Global Tic Severity Scale.

Teva shares were losing 3.49% to $12.98.

Earnings

OraSure Technologies, Inc. (NASDAQ: OSUR) reported better-than-expected fourth-quarter revenues, while earnings per share trailed expectations. The company issued below-consensus guidance for the full year 2020.

The stock moved down 8.71% to $6.50 in after-hours trading.

Offerings

Axovant Gene Therapies Ltd (NASDAQ: AXGT) said it has priced its underwritten public offering of 14.03 million shares at $3.57 per share. Additionally, the company said it is offering to certain investors pre-funded warrants to purchase 3.302 million shares at a price of $3.74999 per pre-funded warrant. All the securities are being offered by the company. It expects to generate gross proceeds of about $65 million from the offering.

The stock slipped 11.64% to $3.87 in after-hours trading.

AEterna Zentaris Inc. (NASDAQ: AEZS) said it has entered into a securities purchase agreement with several institutional investors in the U.S. for the sale of about 3.48 million shares at a price of $1.29375 per share in a registered direct offering priced at-the-market. The company expects to mobilize gross proceeds of $4.5 million from the offering.

In pre-market trading, AEterna Zentaris shares were sliding 13.24% to $1.18.

BioXcel Therapeutics Inc (NASDAQ: BTAI) said it has commenced an underwritten public offering of 2 million shares of its common stock.

BioXcel shares were declining 10.43% to $36.85.

On The Radar

PDUFA Dates

Baudax Bio Inc (NASDAQ: BXRX), which has faced two prior rejections for its intravenous formulation of meloxicam, awaits FDA decision on the investigational pain drug.

Clinical Readouts

Agenus Inc (NASDAQ: AGEN) is scheduled to present on its Investor Day interim analysis of Phase 1 data for balstilimab, or AGEN2034, in cervical cancer. The company will also present Phase 1 data for AGEN1181 in advanced cancer.

Earnings

• Repligen Corporation (NASDAQ: RGEN) (before the market open)
• Pacira Biosciences (before the market open)
• Syneos Health Inc (NASDAQ: SYNH) (before the market open)
• TherapeuticsMD Inc (NASDAQ: TXMD) (before the market open)
• Puma Biotechnology Inc (NASDAQ: PBYI) (after the market close)
• Emergent Biosolutions Inc (NYSE: EBS) (after the market close)
• Cerus Corporation (NASDAQ: CERS) (after the market close)
• Globus Medical Inc (NYSE: GMED) (after the market close)
• PRA Health Sciences Inc (NASDAQ: PRAH) (after the market close)
• NuVasive, Inc. (NASDAQ: NUVA) (after the market close)
• Aerie Pharmaceuticals Inc (NASDAQ: AERI) (after the market close)
• Anika Therapeutics Inc (NASDAQ: ANIK) (after the market close)
• Synthetic Biologics Inc (NYSE: SYN) (after the market close)