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ACRX Nears D-day, TRVN On Watch, All's Well With CRSP, TearLab Disappointed


Today's Daily Dose brings you news about FDA staffers' comments on AcelRx Pharma's pain drug candidate Dsuvia; Audentes Therapeutics' stock offering; FDA lifting clinical hold on CRISPR Therapeutics' investigational drug; TearLab's disappointment, and Trevena's much-awaited regulatory catalyst.

Read on...

Shares of AcelRx Pharmaceuticals Inc. (ACRX) soared more than 35% on Wednesday, following positive comments in the briefing documents related to its investigational drug Dsuvia, proposed for the management of moderate-to-severe acute pain in medically supervised settings in adult patients.

According to the FDA staffers, "The product-user interface supports the safe and effective use of the product by the intended users, for its intended uses, and intended use environments".

On October 12, 2018, a panel of outside experts convened by the FDA is scheduled to review Dsuvia.

Dsuvia, formerly known as ARX-04, consists of 30 mcg sufentanil in very small sublingually absorbed tablets that are delivered via a disposable, pre-filled, single-dose applicator.

This is Dsuvia's second go-around with the FDA. Last October, the FDA had declined to approve Dsuvia, requesting additional data and recommending certain changes to the Directions for Use.

Addressing all the issues, the Company resubmitted the Dsuvia NDA to the FDA in May of this year, which was accepted for review, with a decision date set for November 3, 2018.

ACRX closed Wednesday's trading at $3.59, up 35.66%. In after-hours, the stock was up 7.93% to $3.88.

Audentes Therapeutics Inc. (BOLD) has offered to sell 5.2 million shares of its common stock to the public at a price of $29.00 each.

The gross proceeds to Audentes from the offering are expected to be $150.8 million. The offering is expected to close on October 15, 2018, subject to customary closing conditions.

The underwriters have a 30-day option to purchase up to an additional 780,000 shares of common stock.

To know the near-term catalysts of BOLD, please visit our Emerging Biostocks page.

BOLD closed Wednesday's trading at $29.82, down 18.73%.

Shares of CRISPR Therapeutics (CRSP) were up more than 14% in extended trading on Wednesday, following news of the FDA lifting the clinical hold and accepting the Investigational New Drug application for CTX001 for the treatment of sickle cell disease.

On May 31, 2018, the planned initiation of a phase I/II trial of CTX001 in the U.S. in adult patients with sickle cell disease was put on hold by the FDA.

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex.

The companies remain on track to initiate a phase I/II clinical study in sickle cell disease by the end of 2018 and are currently enrolling patients with transfusion dependent ß-thalassemia in a Phase 1/2 trial in ß-thalassemia in Europe.

CRISPR and Vertex previously announced that they have received the regulatory nod in multiple countries outside the U.S to conduct clinical trials of CTX001 for both ß-thalassemia and sickle cell disease.

CRSP closed Wednesday's trading at $36.64, down 0.57%. In after-hours, the stock was up 14.14% to $41.82.

K2M Group Holdings Inc. (KTWO) has been granted FDA clearance for its Dual Differential Correction Philosophy & Technique.

The DDC philosophy combines rod rigidity and degree of bend with the MESA Platform Technology, to help achieve quality outcomes in patients with sagittal imbalance, the Company noted.

KTWO closed Wednesday's trading at $27.36, down 0.07%. In after-hours, the stock was up 4.53% at $28.60.

SeaSpine Holdings Corp. (SPNE) has commenced an underwritten public offering of shares of its common stock. All of the shares in the offering are to be sold by SeaSpine.

The Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering.

To know more about SeaSpine, please visit our "In the Spotlight" column.

SPNE closed Wednesday's trading at $17.42, down 1.69%.

The FDA has informed TearLab Corp. (TEAR.OB) that its Discovery MMP-9 test has not met the criteria for substantial equivalence based upon data and information submitted in its 510(k) submission.

The TearLab Discovery platform is designed to enable eye care professionals to assess multiple biomarkers in human tears with nanoliter volume tear collection. The lab-on-a-chip platform allows for the measurement of tear proteins in a fully automated workflow that is consistent with the currently marketed TearLab Osmolarity System, widely being utilized by physicians in their practice. The MMP-9 test card will aid in the diagnosis of dry eye disease.

TEAR.OB closed Wednesday's trading at $0.15, down 8.82%.

Trevena Inc. (TRVN), which faces an FDA panel on Thursday with regard to its New Drug Application for OLINVO Injection for the management of moderate to severe acute pain, has been touching new lows since the release of the briefing documents.

The briefing documents, released on Tuesday, have raised issues regarding the safety and abuse potential of OLINVO.

The FDA panel is slated to review OLINVO on October 11, 2018. The regulatory agency's final decision on OLINVO is anticipated on November 2, 2018.

TRVN closed Wednesday's trading at $0.94, down 11.50%. In after-hours, the stock was up 4.54% at $0.99.

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