Clinical

Hydrogel weight-loss pill from Gelesis shows efficacy in overweight adults

November 11, 2019

Most weight loss interventions target obese or super-obese patients who have adjacent comorbidities, such as type 2 diabetes or sleep apnea. But Boston-based Gelesis aims to change that with its hydrogel pill Plenity.

'Cataustrophe' makes AD the demon; AC Immune's effort detailed in webinar

November 10, 2019

By Randy Osborne

No Comments

Within the first few minutes of a key opinion leader webinar on Alzheimer's disease sponsored by AC Immune SA, CEO Andrea Pfeifer brought up the decision by Biogen Inc. to file for regulatory approval of amyloid beta targeter aducanumab in early AD, based on results from a subset of patients in the phase III study called Engage.

Competitor Dermira enjoys boost

Shares sink as Anaptysbio study fails to hit the primary endpoint in AD trial

November 10, 2019

By Lee Landenberger

No Comments

In the wake of each dosing arms' failure to hit the primary endpoint in Anaptysbio Inc.'s phase IIb study of etokimab to treat moderate to severe atopic dermatitis (AD), the stock dropped steeply and the company postponed initiating its phase IIb etokimab trial in eosinophilic asthma until it analyzes the phase IIb result.

Penumbra's EXTRACT-PE study of Indigo Aspiration system hits primary endpoints

November 8, 2019

By Meg Bryant

No Comments

Penumbra Inc. reported final results from its IDE trial of the Indigo Aspiration system at the Vascular Interventional Advances (VIVA) annual meeting in Las Vegas. The Alameda, Calif.-based company said that the EXTRACT-PE trial met its primary endpoints in patients with acute pulmonary embolism (PE).

Allena's shares plunge despite reloxaliase phase III hitting primary endpoint in EH study

November 8, 2019

By Lee Landenberger

No Comments

Allena Pharmaceuticals Inc.'s phase III URIROX-1 trial of reloxaliase hit its primary endpoint, with a statistically significant reduction in urinary oxalate (Uox) in patients with enteric hyperoxaluria (EH), while its phase II Study 206 trial showed reduced plasma oxalate reduction in patients with EH and advanced chronic kidney disease (CKD).

Obseva stock plunges on phase III miss, termination of in vitro fertilization program

November 8, 2019

By Cormac Sheridan

No Comments

DUBLIN – Obseva SA's stock plunged 65% Thursday on news that it was terminating development of its in vitro fertilization (IVF) drug, nolasiban, after it missed the primary endpoint of a confirmatory phase III trial. The result blindsided both Obseva and investors, as the outcome was at odds with that of a previous phase III study, Implant 2, which had demonstrated a statistically significant and clinically relevant improvement in the rate of successful pregnancy at 12 weeks.

ASH abstracts move the market

November 7, 2019

By Lee Landenberger

No Comments

Emerging from the tsunami of abstracts from the nearly here American Society of Hematology (ASH) annual meeting in Orlando, Fla., were data that sent some stocks upward on Wednesday. Most notably, Constellation Pharmaceuticals Inc. (NASDAQ:CNST) was a huge winner as its shares nearly doubled in value as they closed at $28,10, up $13.33, for a gain of 90.25%.

Supernus' non-superlative ADHD try vexing investors, still promise in SPN-812

November 7, 2019

By Randy Osborne

No Comments

Supernus Pharmaceuticals Inc. CEO Jack Khattar said the phase III failure in the study called P301 with SPN-810 (molindone hydrochloride) was "very puzzling" to the Rockville, Md.-based firm, which will be "digging very deep into the data" with hopes of figuring out what went wrong. Shares (NASDAQ:SUPN) closed Wednesday at $19.93, down $9.20, or 31.6%.

Centering itself: Epicentrx launches a phase III in SCLC

November 6, 2019

By Lee Landenberger

No Comments

Corey Carter, whose company Epicentrx Inc. just dosed its first patient in a phase III trial for treating third-line and beyond small-cell lung cancer (SCLC), has made studying the disease a life goal. "With my military background, I noticed that smoking rates are higher there," Carter, the company's president and CEO, told BioWorld. "That's when it became important to me. Then, also, my dad had small-cell lung cancer."

Amgen says it wants the Revolution for its phase Ib

November 5, 2019

By Lee Landenberger

No Comments

Amgen Inc. and Revolution Medicines Inc. will collaborate on a clinical trial evaluating the combination of RMC-4630, Revolution's SHP2 inhibitor, and Amgen's AMG-510, a KRAS-G12C inhibitor. Amgen will conduct the phase Ib trial to treat patients with advanced solid tumors harboring the KRAS G12C mutation and Revolution will provide Amgen with RMC-4630.

Clinical
RSS

Hydrogel weight-loss pill from Gelesis shows efficacy in overweight adults

'Cataustrophe' makes AD the demon; AC Immune's effort detailed in webinar

Shares sink as Anaptysbio study fails to hit the primary endpoint in AD trial

Penumbra's EXTRACT-PE study of Indigo Aspiration system hits primary endpoints

Allena's shares plunge despite reloxaliase phase III hitting primary endpoint in EH study

Obseva stock plunges on phase III miss, termination of in vitro fertilization program

ASH abstracts move the market

Supernus' non-superlative ADHD try vexing investors, still promise in SPN-812

Centering itself: Epicentrx launches a phase III in SCLC

Amgen says it wants the Revolution for its phase Ib

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