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TXMD

TherapeuticsMD

$5.63

0.06 (1.08%)

08:00
07/17/17
07/17
08:00
07/17/17
08:00

TherapeuticsMD drops as TX-004HR update seen not reading 'well at all'

Shares of TherapeuticsMD (TXMD), a women's healthcare company, plunged in pre-market trading after the company provided a regulatory update on the status of its New Drug Application for TX-004HR. REGULATORY UPDATE: In a statement, TherapeuticsMD provided an update on the status of its NDA for TX-004HR, its investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse, saying that it participated in a Type A Post-Action Meeting on June 14 with the FDA's Division of Bone, Reproductive, and Urologic Products. At the meeting, the two sides discussed the complete response letter that TherapeuticsMD previously received for the NDA, which also allowed the company to present new information it believes could address concerns raised in the letter and "positively" impact the status of the NDA. TherapeuticsMD said it has formally submitted the new information for consideration per the FDA's request. However, the company noted that while it continues to have "productive" dialogue with the FDA related to its review, it has not yet received a formal timeline for a conclusion of this review. TherapeuticsMD said it "looks forward" to working with the FDA to address its concerns and sees further clarity on the pathway forward for the NDA "in the coming weeks," adding that it "reserves the right to pursue the FDA's formal dispute resolution process if a reasonable timeline to address such concerns cannot be established." WHAT'S NOTABLE: On May 8, TherapeuticsMD said it received the CRL from the FDA regarding the TX-004HR NDA. At the time, the company said it planned to meet with the FDA as soon as possible to address the concerns raised in the letter, which involved "the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal phase 3 Rejoice Trial." Adam Feuerstein, who previously wrote about biotech stocks for TheStreet and currently is a senior writer for StatNews, tweeted in May that the company lacks the cash to conduct the type of safety study of TX-004HR requested by the FDA, without cutting expenses or raising more money, adding that a delay for this product "could be fatal" for the company. This morning, Feuerstein tweeted that TherapeuticsMD's regulatory update on resolving the CRL "does not read well at all." ANALYST COMMENTARY PRIOR TO UPDATE: Oppenheimer analyst Jay Olson upgraded TherapeuticsMD to Outperform recently ahead of the FDA meeting update, and said there was a "reasonable probability" of positive news. Olson argued that data on complete response letters provides confidence that there are likely no other TX-004HR approvability issues besides lack of long-term endometrial safety data beyond the 12 weeks studied in REJOICE and that there are likely no approvability issues that would have any implications for TX-001HR. PRICE ACTION: In pre-market trading, TherapeuticsMD is down 12%.

TXMD TherapeuticsMD
$5.63

0.06 (1.08%)

05/09/17
OPCO
05/09/17
DOWNGRADE
OPCO
Perform
TherapeuticsMD downgraded to Perform from Outperform at Oppenheimer
Oppenheimer analyst Jay Olson downgraded TherapeuticsMD to Perform saying he's surprised by the FDA's request for long-term safety data. The analyst prefers to move to the sidelines amid uncertainty resulting from the Complete Response Letter.
05/09/17
JEFF
05/09/17
NO CHANGE
Target $15
JEFF
Buy
TherapeuticsMD price target lowered to $15 from $18 at Jefferies
Jefferies analyst Matthew Andrews lowered his price target for TherapeuticsMD to $15 citing a lower probability of success for TX-004HR following the Complete Response Letter. The analyst, with a 55% probability of approval now, believes the FDA's endometrial safety concerns appear addressable. If FDA agrees to approve '004 with a post-approval study, it could obtain a class label with boxed warning, Andrews tells investors in a research note. He keeps a Buy rating on TherapeuticsMD.
05/23/17
STFL
05/23/17
NO CHANGE
Target $20
STFL
Buy
TherapeuticsMD scheduled to meet FDA on June 14, says Stifel
Stifel analyst Annabel Samimy says TherapeuticsMD's Type A meeting with the FDA to discuss last month's Complete Response Letter is scheduled for June 14. The analyst sees two likely scenarios from the meeting. The first has TherapeuticsMD seeking class labeling with a Phase 4 post-marketing study to eventually amend the label. And the second has the company seeking an appeal should FDA hold firm in the 12-month safety requirement to justify a differentiated label. Samimy is "convinced" that TX-004HR remains approvable and she keeps a Buy rating on the shares with a $20 price target.
06/13/17
JEFF
06/13/17
NO CHANGE
JEFF
TherapeuticsMD could use data to push post-approval study, says Jefferies
Jefferies analyst Matthew Andrews says that TherapeuticsMD could use prior data - including a finding that low-dose vaginal estrogen is safe for women with breast cancer and a finding that estrogen delivered in a patch is safe for two years - to convince an FDA panel to allow the company to address concerns raised in a complete response letter for its TX-004 drug with a post-approval study instead of a pre-approval study. Andrews keeps a $15 price target and a buy rating on the shares.

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