Posts tagged FDA approval
CIBC-favored health care stocks for 2018

For 2018, CIBC World Markets is recommending investors hold a basket of healthcare stocks that include a combination of more speculative small and midcap companies with selected large caps.

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Roth ups iRadimed to buy

Roth Capital Partners upgraded iRadimed (NASDAQ:IRMD) to “buy” from “neutral” and raised its price target to $12 from $9 after the company reported second quarter results. The stock closed at $9.80 on July 31.

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HCW starts Agile Therapeutics at buy

H.C. Wainwright launched coverage of Agile Therapeutics (NASDAQ:AGRX) with a “buy” rating and $10 price target, saying the company is significantly undervalued assuming its Twirla combination hormonal contraceptive (CHC) patch can get FDA approval. The stock closed at $4.93 on July 19.

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HCW starts Tetraphase at buy

H.C. Wainwright initiated coverage of Tetraphase Pharmaceuticals (NASDAQ:TTPH) with a “buy” rating and $15 price target. The stock closed at $6.88 on July 10.

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Titan’s Probuphine receives patient testimonial

A patient using Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine six-month implant containing buprenorphine as a new treatment in the battle against heroin and prescription painkiller addiction has documented his experience on Janaburson’s Blog.

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IntelGenx gets oral film exclusivity for tadalafil ED dosing patent

IntelGenx (OTCQX:IGXT; TSXV:IGX) announced that Eli Lilly granted IntelGenx’s VersaFilm an exclusive license for a tadalafil film product under its 6,943,166 erectile dysfunction (ED) dosing patent. Any exclusivity associated with the tadalafil compound patent expiring is not affected by this agreement.  

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Echelon starts Profound Medical at buy

Echelon Wealth Partners initiated coverage of Profound Medical (OTCQX:PRFMF; TSXV:PRN) with a “buy” rating and one-year price target of $4. The stock closed at 78 cents on March 14.

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Roth upgrades Cempra to buy

Roth Capital Partners upgraded Cempra (NASDAQ:CEMP) to “buy” and maintained its $8 price target after the company announced positive Phase 3 results in the first of two skin infection (ABSSSI) studies with Taksta. The stock was quoted at $4.20 near midday on Feb. 27.

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HCW upgrades CymaBay to buy

H.C. Wainwright upgraded CymaBay Therapeutics (NASDAQ:CBAY) to “buy” from “neutral” and raised its price target to $6 from $2 after a revision and update of its revenue and valuation models. The stock closed at $1.67 on Jan. 27.

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Cardiovascular Systems, Kindred on Feltl Top Idea list

Feltl’s Top Ideas list for 2017 includes Cardiovascular Systems (NASDAQ:CSII) and Kindred Biosciences (NASDAQ:KIN).

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Titan’s Probuphine, Behshad Sheldon win Stevie awards

Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant was named a gold award winner at the 13th annual Stevie Awards for Women in Business in the category of "Best New Product or Service of the Year."

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IntelGenx to license tadalafil patent from Lilly

IntelGenx (OTCQX:IGXT; TSX-V:IGX) has signed a binding term sheet to license Eli Lilly's tadalafil dosing patent. Any exclusivity associated with the tadalafil compound patent is not affected by the agreement.

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Aurinia to begin Phase 3 voclosporin trial in Q2

After an end-of-Phase 2 meeting with the FDA, Aurinia Pharmaceuticals (NASDAQ:AUPH) plans to begin a single Phase 3 clinical trial for voclosporin in the treatment of lupus nephritis (LN).

Aurinia believes the Phase 3 trial, whose design is consistent with the ongoing AURA study, will support a NDA submission.

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Titan’s Probuphine gains more media attention

Titan Pharmaceutical’s (NASDAQ:TTNP) Probuphine six-month implant of sublingual buprenorphine continues to attract widespread media attention for its ability to treat addiction to opioids.

Independent TV station, WHDT, in Stuart, FL. has produced a segment on Probuphine with Dr. Stuart Segal and one of his patients, who was successfully weaned off her use of opioids.

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Opioid addiction patient gives high marks to Titan's Probuphine

Today’s edition of USA Today carried a profile of Sarah Wilson, wife and mother of four, who became addicted to opioid pain medications after she suffered severe injuries from being hit by an intoxicated driver about eight-years-ago.

Ms. Wilson started her recovery when she entered a clinical trial that tested Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine six-month implant of buprenorphine.

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Leerink starts Endologix at market perform

Leerink Partners initiated coverage of Endologix (NASDAQ:ELGX) with a “market perform” rating and $13 price target. The stock closed at $12.22 on Friday.

Endologix is the largest abdominal aortic aneurysm (AAA) pure play and holds the No. 4 position in the $1.5-billion worldwide AAA market.

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Braeburn provides update on training sessions for Probuphine

Healthcare provider training and certification for Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant will take place on July 15-17 in Denver by Titan’s marketing partner, closely-held Braeburn Pharmaceuticals.

The FDA cleared Probuphine in late May as the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less a day. Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America.

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Buprenorphine patient limit raised to 275

The Obama Administration will raise to 275 from 100 the limit on the number of patients with opioid addiction that certain physicians can treat with buprenorphine.

The move was part of several announced by the administration as part of an effort to stem the opioid abuse epidemic that is killing nearly 80 people from overdoses every day.

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