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FDA Panel Backs ACRX's Pain Drug, ALL Eyes On EARS, TNDM On Watch

pharma 012617 14oct18 lt

Today's Daily Dose brings you news about AcelRx Pharma's pain medication DSUVIA getting thumbs up from FDA panel; near-term catalyst of Auris Medical; regulatory nod for Grifols' ID CORE XT kit for molecular red blood cell typing; Iovance' public offering and Tandem's t:slim X2 Insulin Pump approval in Canada.

Read on...

An FDA panel on Friday voted 10-3 in favor of recommending approval of AcelRx Pharmaceuticals Inc.'s (ACRX) DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients.

DSUVIA is a 30 mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional, and is designed to provide an easy-to-administer dosage form for rapid relief as early as 15 minutes.

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so. The regulatory agency's final decision is set for November 3, 2018.

Trading in ACRX was halted on Friday. The stock closed Thursday's trading at $3.98, up 10.71%.

Auris Medical Holding AG (EARS) is slated to provide an update on its intranasal betahistine program on Wednesday, October 17, 2018.

The intranasal betahistine program includes AM-125 for the treatment of vertigo, and AM-201 for the treatment of antipsychotic-induced weight gain and somnolence.

The key results from the second phase I trial of AM-125 in healthy volunteers will also be presented on Wednesday.

EARS closed Friday's trading at $0.98, up 44.12%.

Grifols (GRFS), on Friday, received approval from the FDA for its ID CORE XT molecular diagnostic test for molecular red blood cell typing. The blood group genotyping kit has been CE-IVD marked in Europe since 2014.

According to the Company, the ID CORE XT kit will benefit patients who require ongoing transfusions including individuals with hemoglobinopathies such as sickle-cell disease and thalassemia. The kit will also be used for cancer patients who require more thorough blood typing. Other patients who may benefit from the kit include those with warm autoimmune hemolytic anemia, those who have recently received a transfusion and those undergoing daratumumab therapy.

ID CORE XT types simultaneously 37 antigens of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, providing detailed information of the most clinically relevant blood groups, added the Company.

GRFS closed Friday's trading at $19.62, down 0.46%.

Iovance Biotherapeutics Inc. (IOVA) has offered to sell 22 million shares of its common stock to the public at a price of $9.97 each.

The gross proceeds from the offering are expected to be $219.3 million. The offering is expected to close on or about October 16, 2018, subject to customary closing conditions.

The underwriters have a 30-day option to purchase up to 3.3 million additional shares of common stock.

Near-term Catalysts:

-- Initiate enrollment into Cohort 4 of its phase II study of LN-144 in metastatic melanoma in early 2019.
-- Submission of Biologics License Application for LN-144 in metastatic melanoma is expected in the second half of 2020.

IOVA closed Friday's trading at $11.93, up 19.66%.

The United States Court of Appeals for the Federal Circuit has ruled in favor of Mylan N.V (MYL) in the last remaining patent infringement cases against Teva Pharmaceuticals (TEVA) related to the Teva's multiple sclerosis drug Copaxone 40 mg/mL.

The Appeals Court ruled that Teva's Copaxone 40 mg/mL dosing patents are invalid as obvious.

The brand sales of Copaxone for 20 mg/mL dose were approximately $527 million and that of the 40 mg/mL dose were about $2.86 billion for the 12 months ending Aug. 31, 2018, according to IQVIA.

Mylan launched a generic version of Teva's Copaxone 40 mg/mL, as well as a generic version of Teva's Copaxone 20 mg/mL in the U.S. last October.

MYL closed Friday's trading at $32.11, down 1.50%.

Rockwell Medical Inc. (RMTI) anticipates filing a New Drug Application for an intravenous formulation of its proprietary drug Triferic in the fourth quarter of 2018. If all goes well as planned, the Company anticipates the FDA to announce its decision on IV Triferic in late 2019.

Triferic, administered via dialysate, was approved in January 2015 an iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

The Company intends to provide additional information regarding IV Triferic and the planned NDA submission on the Company's third quarter earnings call on November 9, 2018.

RMTI closed Friday's trading at $3.96, down 1.25%.

Tandem Diabetes Care Inc. (TNDM) has received approval to market t:slim X2 Insulin Pump in Canada. The device is expected to be launched in the country on a province-by-province basis throughout the fourth quarter of 2018.

The t:slim X2 Pump features Dexcom G5 Mobile CGM integration, making it the only CGM-integrated insulin pump approved in Canada for making daily diabetes treatment decisions without fingersticks.

The device was approved in the U.S. in June of this year.

According to the Company, the t:slim X2 Pump is up to 38% smaller than other insulin pumps and holds up to 300 units of insulin.

Last month, the Company boosted its sales guidance for 2018 to $150 million to $158 million from its prior forecast of $140 million to $148 million, following continued domestic demand and the recent launch of the t:slim X2 Insulin Pump in select international markets.

TNDM closed Friday's trading at $36.13, up 5.21%.

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