The Daily Biotech Pulse: Correvio Faces FDA Panel Rejection, Iterum's Antibiotic Trial Narrowly Misses Primary Endpoint

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 Dec. 10)

• Acceleron Pharma Inc XLRN
• Aimmune Therapeutics Inc AIMT
• argenx SE – ADR ARGX
• ArQule, Inc. ARQL(agreed to be bought by
• Arvinas Inc ARVN
• Audentes Therapeutics Inc BOLD
• Aurinia Pharmaceuticals Inc AUPH
• Axsome Therapeutics Inc AXSM
• Avadel Pharmaceuticals PLC AVDL
• Bausch Health Companies Inc BHC
• BridgeBio Pharma Inc BBIO
• Bristol-Myers Squibb Co BMY(reacted to ASH presentation)
• Deciphera Pharmaceuticals Inc DCPH
• Eidos Therapeutics Inc EIDX
• Flexion Therapeutics Inc FLXN
• Forty Seven Inc FTSV
• GALAPAGOS NV/S ADR GLPG
• GlaxoSmithKline plc GSK
• Global Blood Therapeutics Inc GBT
• Gossamer Bio Inc GOSS
• Immunomedics, Inc. IMMU
• Incyte Corporation INCY
• IVERIC bio Inc ISEE
• The Medicines Company MDCO
• Merck & Co., Inc. MRK
• Morphosys Ag MOR
• Neoleukin Therapeutics Inc NLTX
• Principia Biopharma Inc PRNB
• Repro-Med Systems, Inc. KRMD
• Sanofi SA SNY( announced measures to drive innovation and growth)
• SpringWorks Therapeutics Inc SWTX
• TG Therapeutics Inc common stock TGTX
• Xenon Pharmaceuticals Inc XENE

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 10)

• Achieve Life Sciences Inc ACHV
• Cabaletta Bio Inc CABA
• Checkpoint Therapeutics Inc CKPT
• CNS Pharmaceuticals Inc CNSP
• Endologix, Inc. ELGX
• Galectin Therapeutics Inc. GALT
• Idera Pharmaceuticals Inc IDRA
• MEREO BIOPHARMA/ADR MREO
• Orgenesis Inc ORGS
• Tetraphase Pharmaceuticals Inc TTPH
• Tonix Pharmaceuticals Holding Corp TNXP
• Unum Therapeutics Inc UMRX

Stocks In Focus

Correvio's Brinavess Receives Thumbs Down From FDA Panel

Correvio Pharma Corp CORV said FDA's Cardiovascular and Renal Advisory Committee, which reviewed its Brinavess, voted that the benefit-risk profile was not adequate to support approval, with two staffers voting for the drug and 11 against.

The FDA has set a PDUFA action date of Dec. 24 for approving the drug.

The stock tumbled 57.14% to 60 cents in after-hours trading.

Xeris Reports Positive Mid-Stage Results For Low Blood Sugar Therapy Following Weight-Loss Surgery

Xeris Pharmaceuticals Inc XERS announced positive top-line results from the in-clinic part of a Phase 2 study of its developmental ready-to-use, or RTU, glucagon in patients who experienced post prandial hypoglycemic episodes following bariatric surgery.

The study showed that of patients with a successful meal challenge, all subjects were able to self-administer a mini dose of study drug, as directed, during the setting of declining blood glucose. A mini dose of RTU glucagon was sufficient to restore or maintain normal blood glucose level within 15 minutes of administration. The incidence of follow-on episode of hypoglycemia was less with a mini dose of RTU glucagon compared to placebo.

"Mini doses of RTU glucagon appear safe and well tolerated, and no serious adverse events occurred," the company added.

The stock climbed 11% to $9.99 in after-hours trading.

Diffusion Presents Positive Efficacy Data For Brain Cancer Treatment

Diffusion Pharmaceuticals Inc DFFN presented data from the open-label, dose-escalation Phase 3 study of Trans Sodium Crocetinate, or TSC, plus standard of care, or SOC, that showed that the investigational compound increased survival in inoperable glioblastoma multiforme patients. The findings were presented at the inaugural Glioblastoma Drug Development Summit in Boston.

In the 19-patient study, safety was demonstrated in all patients receiving TSC at all dosing levels.

The stock jumped 26.85% to 55 cents in after-hours trading.

See also: 5 Stocks Moving On ASH Presentations

Novartis Make Regulatory Submission For Xolair Label Expansion

Novartis AG NVS said the FDA has accepted its sBLA for Xolair for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. The PDUFA date is likely to be by the third quarter of 2020. Xolair has already been approved for treating moderate-to-severe or severe persistent asthma in over 90 countries.

Flexion's Chief Scientific Officer and Co-founder To Retire

Flexion said Neil Bodick, its chief scientific officer and co-founder, will retire, effective Jan. 3, 2020. Following his resignation, Bodick will continue in a consulting role, as part of the transition of his responsibilities.

The stock added 3.87% to $21.76 in after-hours trading.

Iterum's Antibiotic Candidate For cIAI Narrowly Misses Primary Endpoint

Iterum Therapeutics PLC ITRM said its SURE 3 clinical trial that evaluated its sulopenem compared to ertapenem in complicated intra-abdominal infections did not meet the primary end point of clinical response on Day 28 in the micro-NITT population.

The difference in outcomes was 4.7% with a 95% confidence interval on that differences of -10.3% to 1%. The company noted that non-inferiority required that the lower limit of the difference in the outcome rates to be more than or equal to -10%.

The stock plummeted 40.21% to $2.90 in after-hours trading.

Hepion's NASH Drug Study Advances to Next Higher Dose In a Phase 1 MAD Study

Hepion Pharmaceuticals Inc HEPA said it has successfully advanced to the next higher dose in the ongoing Phase 1 multiple ascending dose, or MAD, study of CRV431.

"The data generated from this trial is expected to guide further development of CRV431 for the treatment of NASH, with plans to initiate Phase 2 clinical studies in the first half of 2020," the company said.

The stock gained 4.52% to $5.78 in after-hours trading.

Offerings

Aquestive Therapeutics Inc AQST said it intends to sell $35 million worth of shares of its common stock in an underwritten public offering. All shares are being sold by the company. It intends to use the net proceeds for the commercial launch of Sympazan, among other things.

The stock slipped 15.45% to $6.35 in after-hours trading.

Orthopediatrics Corp KIDS said it is commencing an underwritten public offering of its common stock. The offering will also include shares offered by certain selling shareholders, the proceeds of which will no be received by the company.

The stock moved down 7.86% to $35.54 in after-hours trading.

Rocket Pharmaceuticals Inc RCKT said it has priced an underwritten public offering of 3.82 million shares at $22.25 apiece. The company expects to raise gross proceeds of $84.995 million from the offering. The offering is expected to close on or about Dec. 13.

The stock declined 5.41% to $22.92 in after-hours trading.

Momenta Pharmaceuticals, Inc. MNTA said it has commenced an underwritten registered public offering of $200 million worth of its shares. All the shares are being offered by the company.

The stock fell 3.43% to $17.45 in after-hours trading.

Madrigal Pharmaceuticals Inc MDGL said it has priced its previously-announced underwritten secondary offering of 1.2 million shares by investment funds affiliated with Bay Capital at $107.85 per share. The offering is set to close on or about Dec. 13. The company said it will not receive any proceeds from the offering.

The stock retreated 7.17% to $110 in after-hours trading.

Marinus Pharmaceuticals Inc MRNS said it intends to offer shares of its common stock in an underwritten public offering. All the shares are to be sold by Marinus. Concurrent with the offering, the company also plans to sell in a private placement, a number of convertible preferred shares, equal to an aggregate purchase price of up to approximately $30 million at the price of the common stock offering.

The stock dipped 10.08% to $1.16 in after-hours trading.

On The Radar

Clinical Readouts

San Antonio Breast Cancer Symposium Presentations

MacroGenics Inc MGNX and Zai Lab Ltd ZLAB – oral presentation of detailed results from the second interim overall survival analysis form the SOPHIA study of margetuximab in patients with HER2-positive metastatic breast cancer who have been previously treated with anti-HER2-targeted therapies

Seattle Genetics, Inc. SGEN – already-released Phase 2 data for Tucatinib ONT-380 in combination with Roche Holdings AG Basel ADR RHHBY Herceptin and oral chemotherapy Xeloda in HER2+ metastatic breast cancer

G1 Therapeutics Inc GTHX – additional Phase 1b data for Lerociclib plus AstraZeneca plc AZN's Faslodex in ER+ breast cancer